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Post by lakers on Dec 23, 2015 3:12:03 GMT -5
Current Status Delayed Explanation of Status The protocol finalization date, April 2015, was missed due to ongoing discussions with the Agency. The applicant proposed a revised protocol finalization milestone of April 2016. FDA determined that the applicant had good cause for their failure to comply with the milestones of the original timetable and acknowledged the revised milestones in a letter dated September 29, 2015. www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
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Post by lakers on Dec 21, 2015 19:29:48 GMT -5
The new CEO news is very close. $1.50 stock option and/or RSU is very attractive to him, good upside potential. The company normally lets the new CEO announce good news to build up his capital of credibility to Wall St and SH.
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Post by lakers on Dec 21, 2015 17:13:08 GMT -5
Lakers, I also feel that Sanofi will be around and is not going anywhere. The disappointment (one of them) I have right now is the last CC they stated we would have a partnership announced by the end of the year, not much time left for that to happen. Hakan quickly added "or 1Q16". [thankfully. He shouldn't have publicly announced a deadline lest Mnkd lost negotiating leverage.]
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Post by lakers on Dec 21, 2015 15:10:12 GMT -5
1. Sanofi partnership remains STRONG, going full tilt in 1Q16. I unequivocally believe the death of the partnership has been greatly exaggerated. You can stop doubting it now. For non-believers, you can write off for tax now if it makes you sleep better. But if you are still in, absolutely don't lose sleep over it.
2. Pain mgmt partnership being guided actively by CMO
3. Questions on cash on balance sheet will be addressed in 4Q15 Feb ER CC(had a typo).
4. New CEO most likely TBA 1Q16.
5. PAH: Working on selecting an optimal, commercially viable API
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Post by lakers on Dec 18, 2015 16:53:07 GMT -5
Schwab rate drops from 15 to 12% @12:42PM PST 12/18/15.
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Post by lakers on Dec 18, 2015 15:38:50 GMT -5
A Guest Post on Afrezza by Jeremy Pettus I wanted Dr. Jeremy Pettus to write today about Afrezza. My tune on this med has changed slightly after Dr. Steve Edelman and I put on a very interesting focus group on a during the first weekend of December to discuss the medication. The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. Read more: mnkd.proboards.com/user/1882/recent#ixzz3uht2OYR4
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Post by lakers on Dec 18, 2015 2:37:53 GMT -5
Now that Pediatric Trial started recruiting since Oct 2015, Sny insulin qualification must be just completed very recently. As such, Mnkd will get $25M dev in 1Q16. Pediatric Phase 1 should finish 1Q16. The 8-10K PWD lung trial w/ protocol decided by 4/30/16 w/ FDA and EMA will cause a huge increase in free TRx of which cost will be borned by Sanofi alone. Thus, Sanofi has an incentive to supply its insulin for Afrezza to minimize the expense. Things are coming together finally.
Matt's slides showed Mnkd has been qualifying Sanofi's insulin and planning international expansion. This is to be followed by label improvement, superiority trials of which protocol would be forklifted from the 12 early adopters' experience shared at Del Mar Hilton, SD. It all makes sense now.
Sanofi needs to obtain superiority label to justify charging high price and move Afrezza to Tier 2. Although I don't want to recommend any investment, what liane has been doing made sense.
Hope these bring visibility and clarity to the Old Faithful's.
BTW, Matt is traveling on a business trip. His email response will be slow. Roberta will be back tomorrow Fri.
You can verify all these if you don't want to take them with a grain of salt. I recommend you at least try before passing judgment.
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Post by lakers on Dec 18, 2015 1:52:46 GMT -5
GLP-1 and GLP-1/Basal Combos: Lyxumia, Lixilan, & Xultophy Sanofi, having brought two new drugs to the US market in 2015 with Mannkind’s Afrezza and their new basal Toujeo, is quickly working to follow that up with their GLP-1 agonist and GLP-1/basal insulin combination drugs in the United States. Sanofi filed for New Drug Appliaction (NDA) with FDA for its GLP-1 agonist Lyxumia (lixisenatide) in September 2015. Once approved, we expect approval for Lixilan (Lyxumia+Lantus) to be right on its heels. Combination drugs are certainly a big market in type 2 therapies right now. Novo Nordisk’s Xultophy, a combination of their commercially successful GLP-1 agonist Victoza and their brand new basal insulin Tresiba, also had its NDA put in front of FDA in September and will likely beat Lixilan to market. Xultophy is already approved in Europe, but was held up here until its Tresiba component could be approved. We expect to see all three of these GLP-1 drugs available in pharmacies by next year’s end. Novo’s New Novolog and a Long-Acting from Lilly Novo Nordisk has another game-changer up its sleeve, as well, having announced just last week that an NDA has been filed for a newer, speedier version of Novolog (insulin aspart) for treatment of type 1 and type 2 diabetes. According to their press release, the “faster-acting insulin aspart contains a short-acting insulin and two well-known excipients, a vitamin and an amino acid, to increase the initial absorption rate and an earlier blood sugar lowering effect.” What does this mean for people with diabetes? Better post-prandial (post-meal) blood glucose control. Bring it on. Another insulin coming to us in 2016 is Lilly’s new basal insulin, Basaglar – a form of insulin glargine (which you may recognize if you’re familiar with Lantus). FDA approved it just this week after a patent dispute was finally resolved with Sanofi. As stated in the FDA press release, “Basaglar is the first insulin product approved through an abbreviated approval pathway” because it is “sufficiently similar to Lantus to justify reliance.” Lantus’s patent expired in 2015 and it will be interesting to watch glargine’s progress under a competing label. Another note of interest is that Basaglar is not approved as a biosimilar product, as the manufacturer must actually apply for biosimilarity through a specific application process. As Merck and other companies prepare for a rollout of their own forms of insulin glargine in the coming years, we hope that choice in basal insulin therapy will increase for patients and that prices…perhaps…decrease. Nasal Glucagon In October, we were thrilled to learn that Eli Lilly & Company acquired the rights to Montreal-based Locemia’s novel nasal glucagon. Easy to carry, easy to dose, easy to implement, nasal glucagon will do for people with diabetes what the Auvi-Q has done for people with allergies – make a life-saving, every-second-counts emergency treatment fairly fool-proof to administer. Will we see it come to market in 2016? We hope so. Locemia had said they planned to submit to FDA in late 2015, early 2016, so it’s our best guess that Lilly might follow a similar timeline. asweetlife.org/feature/7-new-diabetes-products-to-look-for-in-2016/
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Post by lakers on Dec 17, 2015 21:35:58 GMT -5
FDA approves Lilly and Boehringer's take on Sanofi's top-selling insulin Partners Eli Lilly ($LLY) and Boehringer Ingelheim inched closer to challenging Sanofi's ($SNY) best-selling insulin, winning FDA approval for their take on the blockbuster Lantus as they wait for its U.S. patent protection to expire. The agency signed off on Basaglar, a long-acting insulin analog that demonstrated itself similar to Lantus, which brings in nearly $8 billion a year for Sanofi. The FDA's approval follows a "tentative" OK for Basaglar handed down last year, in which the agency recognized that Lilly and Boehringer's product stacked up to Lantus but held off on clearing the treatment until the two parties resolved a legal dispute. Now, thanks to a patent settlement signed in September, Lilly and Boehringer are preparing to launch their insulin in the U.S. after Lantus' market exclusivity expires on Dec. 15, 2016. The pair began rolling Basaglar out in Europe this fall but, due to the slow process of convincing physicians to switch patients' prescriptions, haven't seen the rapid uptake commonly seen with generics. The Basics of Biotech 101, 201 & 301 - Price: $299 This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now. Sign up for our FREE newsletter for more news like this sent to your inbox! The coming threat of competition for Lantus puts Sanofi on notice as the French drugmaker works to prop up its once-growing diabetes business in the face of global headwinds. Earlier this year, the company disappointed analysts with the revelation that it expects diabetes sales to slip about 7% in 2015 and decline well into 2018, as new products--including Toujeo, a longer-acting heir to Lantus--have failed to live up to expectations. In the weeks since, Sanofi has signed deals worth up to $6 billion to bring in pipeline treatments that might help it contend with Lilly, Novo Nordisk ($NVO) and Johnson & Johnson ($JNJ), rivals that have since eclipsed its place in parts of the diabetes market. As for Lilly, the promise of cutting into Lantus' revenue with Basaglar could help the company move on from a costly failure tied to an insulin of its own. Earlier this month, the company called it quits on a massive late-stage effort to develop a once-a-day insulin that would compete with Toujeo and Novo's Tresiba, nixing plans to seek FDA approval after finding some alarming safety signals in its 6,000-patient Phase III program. www.fiercebiotech.com/story/fda-approves-lilly-and-boehringers-take-sanofis-top-selling-insulin/2015-12-16[Sanofi needs T&A to do well more than ever]
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Post by lakers on Dec 16, 2015 21:09:47 GMT -5
Business Spotlight: Lessons Learned By Jana Adkins SCVBJ Editor October 27, 2014 12:00 p.m. How MannKind Would Change How They Conduct Clinical Trials in the Future Hakan Edstrom, President, COO and board member of MannKind. Originally from Sweden, Edstrom is a longtime resident of the Santa Clarita Valley. SCVBJ: Would you briefly describe the history of MannKind in bringing Afrezza from concept, to development, to R&D and then to FDA approval? And how many years long was that journey? MannKind history dates back to early 1990s, however, at that time we were known as PDC – Pharmaceutical Development Corp. The focus on diabetes began in the late 1990’s when Chairman Al Mann got exposure to the technology in one of the earlier companies he had founded. In 2001 MannKind focused on the development of diabetes treatment Afrezza. It’s been a costly development. I’m really happy to say that through the persistence of our people the FDA advisory committee gave us an overwhelming approval in April, and in June we successfully brought Afrezza through the FDA approval process. So many patients from the clinical trials lined up to speak at the FDA panel meeting that they had to be restricted to three minutes each. Those patients spoke based on their own initiative and paid their own way to speak before the FDA panel. It was very compelling and very inspirational to hear how Afrezza made a difference in their lives. SCVBJ: How big is the market for Afrezza? Diabetes is such a humongous market. We expect this to be a multi-billion dollar product. In the U.S. alone, about $7 billion is spent on insulin therapy alone. It is a disease that unfortunately has reached epidemic proportions on global basis. The belief is that by 2050, one in three Americans might be suffering from diabetes. Those states are very scary. As a society we can’t afford to take care of big portion of the population with such a chronic disease. Insulin therapy Has always been a treatment of last resort, and there are some issues with insulin injections. Afrezza addressed those issues and makes the therapy more attractive to patients and doctors which can result in higher compliance. Our product’s ease of administration and faster-acting is quite a therapeutic benefit to the patient – and there are no needles involved. Using the inhaler, Afrezza gets into the blood very fast meaning patients can sit down at use it at meal time. Today, injections require patients thinking about what time they will start eating and how to time their injections 30 to 45 minutes in advance for the insulin to reach full concentration in the blood. There’s a risk to injecting it too early or too late. Afrezza also works for children with diabetes. They don’t want to inject themselves and today most schools don’t have school nurses or places where they can go and inject themselves in privacy. This helps children stay compliant and it's easier for them to administer and control. SCVBJ: What was the wait for FDA approval like? The regulatory process has been long and has been hard, as can be expected for products to be used for lifetime chronic therapy. Part of the delay was that there was another inhaled product a few years back, but unfortunately it really didn’t have any clinical benefits over existing therapies at the time and it was a lot more expensive. That created a little bit of bias about our product. And dealing with the FDA was always a challenge. They certainly have strict requirements. It’s expensive and usually takes a long time. Our product is a combination product of a drug and a device, so even more complicated, and it had to be reviewed by several divisions and bureaus of the FDA. One meeting I attended had 22 FDA representatives. It was a bigger challenge than we had expected and took longer. We had more than 6,340 patients involved in our clinical trials lasting from one to two 2 years. It was very comprehensive and very expensive but we really felt we had something that could make a change in peoples’ lives. The tenacity was there; there conviction was there in our employees. SCVBJ: How did it feel when the company had to lay off employees in 2011? It was very unfortunate and difficult in 2011 when we had to lay off employees while we waited for approval. Particularly when you feel like you have very committed, talented people sitting in ‘regulatory hold’ until you know exactly how to move forward. But now we’re in an aggressive hiring mode, especially at our Danbury, Connecticut manufacturing site. But a lot of the people that we had to let go, we’re re-hiring. It’s a sign that we must have been doing something right that people were willing to come back and work with us again. We’re very proud of that. SCVBJ: Now that Afrezza is approved, what did success feel like? We felt like what we’ve been fighting for, for such a long time, and our tenacity for our conviction and our commitment that we were able to convince the FDA product was safe – that feeling was great. We partied at individual sites and we’re planning to have our biggest party during the first quarter of 2015 when our global partner, Sanofi, will launch the product. They are working very hard to come out with the product and launch the product in the United States and on a global basis. SCVBJ: What lessons were learned along the way about how to bring a new drug to market?
In hindsight it’s always a learning process as to how to benefit going forward. Going forward, we would conduct some of the clinical studies in a different manner if we did it again. We would probably do comparative clinical studies with other therapies for patients and show the superiority or benefit of Afrezza over competitive products.
We probably did not give ourselves the optimum ‘label’ (product description) that the product deserves where you can show and differentiate your product from other therapies – showing the incidence of hyperglycemia, high blood sugar, or the recipe of how you can use the product and what you can expect from it, like a prescription advisory to doctors and patients.
The benefit would been an even stronger differentiation of benefits for Afrezza as compared to parallel therapies for Type I and type II therapies. It makes it easier to sell the product and presents stronger arguments to present to doctors and patients; why they should use our product as opposed to alternative. It eventually gives you a stronger franchise and better opportunity for higher sales.
When you do clinical studies for the FDA you’re trying to prove you have a worthy product and show overall safety and efficacy. We were more focused on the clinical side of our studies given history with Pfizer’s (diabetes) medication and other studies than comparing our treatment to others on the market; we wanted a really clean study. The studies are very expensive and we were being careful about how we managed shareholder investments.
Now with an approved product we can do all of the studies and we’ll certainly turn our focus to showing the superiority of the product in therapy. [Sny should/could have started this last year. JAC was admittedly asleep at the wheel.] We are certainly very happy to have a company like Sanofi, which is represented in 120 countries worldwide. It’s a tremendous opportunity to expand to many parts of the world. Editor’s Note: The license agreement between MannKind and Sanofi will give MannKind an upfront payment of $150 million and potential milestone payments of up to $775 million. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65 percent and MannKind receiving 35 percent. www.signalscv.com/m/section/434/article/129140/
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Post by lakers on Dec 15, 2015 18:17:14 GMT -5
investors.mannkindcorp.com/secfiling.cfm?filingID=1193125-15-403752&CIK=899460Pg S-7 This prospectus supplement relates to the resale, in one or more offerings, of up to an aggregate of 159,303 shares of our common stock that we may issue upon exercise of warrants held by the selling stockholders. The table below provides information about the beneficial ownership of each selling stockholder as to: • the number of shares that are currently, or potentially will be, beneficially held by the selling stockholder (assuming full exercise of the warrants); • the maximum number of shares that may be offered by the selling stockholder under this prospectus supplement; and • the number of shares to be beneficially held by the selling stockholder following the offering (assuming that the maximum number of shares that may be offered by the selling stockholder hereunder are so offered, and no other shares are beneficially acquired by the selling stockholder). We cannot state with certainty the number of shares of our common stock that will be beneficially owned by the selling stockholders after completion of this offering because the selling stockholders may not fully exercise the warrants and may subsequently acquire beneficial ownership of other shares of our common stock. Our registration of these shares does not necessarily mean that the selling stockholders will dispose of any or all of the shares. The information provided in the table below as to number of shares beneficially owned prior to the offering is based on information provided by the selling stockholders. The information provided below is as of December 1, 2015, as of which 428,661,136 shares of our common stock were outstanding. Name and Address Number of shares
beneficially
owned prior
to the offering (1)(2) Number of shares offered hereby (1) Number of shares beneficially owned following the offering (2) Amnon Mandelbaum
c/o Sunrise Securities Corp. 630 Fifth Ave, 31st floor New York, NY 10111 64,199 64,199 0 NLBDIT 2010 Services LLC (3) 175 Great Neck Rd., Ste. 403 Great Neck, NY 11021 34,569 34,569 0 S.H.N. Investments Ltd. (4) 8 Abba Even Blvd. Hertzlyia Israel 60,535 60,535 0 (1) Represents shares of common stock issuable upon exercise of the warrants. (2) Percentage of shares beneficially owned prior to and following the offering does not exceed 1%. (3) Samir Masri, Manager of NLBDIT 2010 Services LLC, may be deemed to have sole voting and dispositive power with respect to the shares held by or issuable to NLBDIT 2010 Services LLC. (4) Each of Nir Shamir, Chief Executive Officer of S.H.N. Investments Ltd., and Hadar Sharmir, Chairman of S.H.N. Investments Ltd., may be deemed to have shared voting and dispositive power with respect to the shares held by or issuable to S.H.N. Investments Ltd.
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Post by lakers on Dec 15, 2015 17:05:47 GMT -5
Form 8-K for MANNKIND CORP
15-Dec-2015
Other Events, Financial Statements and Exhibits
Item 8.01 Other Events. On December 15, 2015, MannKind Corporation filed a prospectus supplement to its effective shelf registration statement on Form S-3 (Registration No. 333- 206778) filed with the Securities and Exchange Commission. This Current Report is being filed solely for the purpose of filing the opinion of Cooley LLP relating to the legality of the issuance and sale of the shares set forth in the prospectus supplement, which opinion is attached as Exhibit 5.1 hereto.
Item 9.01 Financial Statements and Exhibits. (d) Exhibits.
Exhibit No. Description
5.1 Opinion of Cooley LLP.
23.1 Consent of Cooley LLP (included in Exhibit 5.1).
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Post by lakers on Dec 15, 2015 12:23:53 GMT -5
Dosing protocol, CGM for a superiority trial design Real-World Afrezza: Focus Group Feedback and Giving Inhaled Insulin a Second Try Welcome back to another post in our periodic "Afrezza in the Real World" series, chronicling the real-life experiences of people with diabetes using the new Afrezza inhaled insulin. You may remember that our own AmyT here at the 'Mine has been using Afrezza since March, and is still enjoying its quick action for bolus doses and between-meal BG corrections. Anyone following me on social media may remember that I tried Afrezza myself in a brief trial-run back in September. Although I was impressed to see how quickly Afrezza could lower my blood sugar compared to how long it takes regular insulin to kick in, I ended up deciding it wasn't a long-term choice for me -- in part because I worry about the possible effects on the lungs that no one can foresee at this point, but also because of the lack of insurance coverage and cost aspects. Real World AfrezzaAs always, YDMV (Your Diabetes May Vary), and we hear from many folks having very positive experiences with it. Unfortunately, that may not be the case for much longer, as Sanofi is currently deciding how to proceed with this drug in the face of disappointing sales numbers for 2015. Afrezza's future is uncertain and Sanofi could potentially drop Afrezza from its production lineup at the start of 2016. If that happens, Mannkind would have to find a new partner to manufacture, market and sell Afrezza. Whatever happens, many are enjoying the Afrezza experience in the meantime, and we're happy to continue sharing their various stories here as part of our #RealWorldAfrezza series. Today, we hear from renowned endocrinologist and type 1 himself Dr. Jeremy Pettus in San Diego, CA, who's just recently decided to start using Afrezza again after a failed first try. Jeremy also works with the beloved Taking Control of Your Diabetes (TCOYD) conference series, and runs the We Are One Diabetes group for PWDs who work professionally in diabetes. A Guest Post on Afrezza by Jeremy Pettus I wanteJeremy Pettusd to write today about Afrezza. My tune on this med has changed slightly after Dr. Steve Edelman and I put on a very interesting focus group on a during the first weekend of December to discuss the medication. The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. [Rumor of Sny dropping Afrezza doesn't match the intent of designing a clinical trial around this info. Label improvement was part of Sny road map all along. See Mnkd's previous slides if you can dig it up] Some of the comments we heard during the focus group: A big takeaway from this focus group meeting: There are people out there using this medication very well to achieve crazy-low A1Cs, like in the 5s, along with low rates of hypoglycemia. I mean these people got pissed when their BG was above 130! So how are they doing it? Well, let me back up a second first and explain my first experience with Afrezza. Basically when I first took it, I took 4 units and then ate a sandwich. An hour or so later, my BG was over 250mg/dL, so I thought it didn’t work and never took it again. Turns out my experience is somewhat common. The reason for this is that one unit of Afrezza is NOT equal to one unit of subcutaneous insulin. In fact, inhaling 4 units of Afrezza is closer to injecting 2.5 or 3 units. So basically, I dramatically under-dosed myself. Now that I know that, I have been trying Afrezza for the last couple days, taking the right dose at the start of a meal or even 10 minutes into it and being slightly more aggressive. The really nice thing about the drug is that it works really, really fast but then totally hits the brakes. Yesterday, I had a high of ~250 BG, took 8 units of Afrezza and my BG came screaming down with two down arrows on the CGM. I started to get nervous, but by like an hour into it, my BG totally flattened out without going low. So it truly is rapid-on and rapid-off. Yes, it takes some getting used to the new dosing regimen, inhaling something that can make you cough initially, and whipping out something that resembles a crack pipe in public always makes for some interesting reactions. But overall, it does fit an unmet need and has its place in our world. You should have heard some of these comments from people in the focus group talking about their control. One guy was “complaining” that the high alarm on the Dexcom should let you go lower than 120mg/dL... wow! Can you imagine setting your HIGH alarm at 120?! He was saying this because he really was achieving perfect control, mostly by controlling that annoying post-meal spike. If you can control that, you'll never again have to deal with the all-too-common scenario of correcting for a high post-meal BG which makes you go low, then raiding the fridge, eat everything in sight and yelling at your significant other “don’t tell me what to eat!”... And then going high again, having to rage bolus 20 units of insulin, and then going low again and repeating. I call it being on the rollercoaster, but instead of being fun like an actual rollercoaster, it just sucks. Afrezza seems to take care of this rollercoaster effect (see also glucoastering) very well. Advertisement I mention this also because there are murmurings about the drug being discontinued in the near future because it is not selling well. I think this mostly comes from providers (not patients) being uncomfortable with the drug given all the things I mentioned above that are new. So if you haven’t tried it, or the doctors haven't offered or discussed it with patients, time might be running out! I took Afrezza for a couple days on samples, but then had a lag and haven't picked up my script, so I don't have any hard data to look at as to how well it did for me. Overall, I think the point is that there's a learning curve. Most type 1s have been on subcutaneous injections for a long time -- decades even, so this is kinda like starting over again and relearning how the drug effects you and your blood sugars. I'm hoping to learn quickly (using my CGM) how to dose Afrezza and see if I become a full-time convert. Thanks for sharing your POV, Jeremy. Like you, we are nervous about the inhaled insulin's future, and hope to see it stick around as a valuable tool for us PWDs. Click on www.healthline.com/diabetesmine/afrezza-focus-group-feedbackTo see picx of 13-person focus group in SD incl. Sam, Eric, Dr Edelman, et al
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Post by lakers on Dec 15, 2015 11:51:49 GMT -5
No. The only remarks made publicly by either company refer only to Sanofi's pre-submission planning. 1Q16: EU, ME MAA submissions. A well-prepared submission is normally approved faster. A reasonable effort includes international expansion in major Territories. The rumors of early partnership termination is greatly exaggerated.
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Post by lakers on Dec 15, 2015 3:23:10 GMT -5
Page 39 of 41 shows nice timeline. The assessment of an application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is interrupted by at least one ‘clock-stop’ during which time the applicant prepares the answers to questions from the CHMP. The clock stop happens after day 120 and may also happen after day 180, when the CHMP has adopted a list of questions or outstanding issues to be addressed by the company. Related discussions are listed in the agenda under sections 3.2 (Day 180 List of outstanding issues) and 3.3 (Day 120 list of questions). CHMP discussions may also occur at any other stage of the evaluation, and these are listed under section 3.4, update on ongoing new applications for centralised procedures. The assessment leads to an opinion from the CHMP by day 210. Following a CHMP opinion the European Commission takes usually 67 days to issue a legally binding decision (i.e. by day 277 of the procedure). CHMP discussions on products that have received a CHMP opinion and are awaiting a decision are listed under section 3.6, products in the decision making phase. www.ema.europa.eu/docs/en_GB/document_library/Agenda/2015/12/WC500198841.pdfDates 12/14/15
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