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Post by lakers on Jan 31, 2017 19:04:04 GMT -5
Matt will update on pipelines on 2/1/17 since Ray won't be there.
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Post by lakers on Jan 29, 2017 19:26:25 GMT -5
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Post by lakers on Jan 29, 2017 16:23:47 GMT -5
Last year 1/27/16, Mnkd announced that it'd hold a Corp dev CC on 2/3/16. That's 5 biz day notice. This year, it's 3 biz day notice, perhaps to satisfy SEC rule?
Most likely, Mnkd will attend RBC Capital Markets 2017 Global Healthcare Conference on Thursday, Feb. 23, at the Lotte New York Palace in New York City.
An ER will likely follow on Mon 3/13/17.
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Post by lakers on Jan 29, 2017 13:32:27 GMT -5
Corporate development refers to the planning and execution of strategies to meet organizational objectives. The kinds of activities falling under corporate development may include management team recruitment, phasing in or out of markets or products, arranging strategic alliances, identifying and acquiring companies (M&A), securing corporate financing, divesting of assets or divisions, and management of intellectual property. The activities encompassed are often the role of the CEO.
CCO being present means partnership. Furthermore, By this time last year, there were low balled partnership proposal due to the perceived short runway and Afrezza commercial failure. Matt said BoD didn't want those deals.
This time though Afrezza still hasn't had traction, the pending label change, trials, multiple ex-US filings, TV Ads, reality shows, more testimonials, more lives covered, longer runway telegraph potential partners that the franchisor would do its part to vigorously promote Afrezza thereby benefiting the franchisees. Think of it as coordinated multiple Afrezza launches.
Moreover, EpiHale IND is due early 1Q17. As such, it's likely there are interesting potential partners as Rose alluded to (posted earlier in this thread).
Many rightly criticized why Al didn't hold a CC when Mnkd inked the partnership with Dr Evil. In hindsight that portended a failed partnership.
This time, BoD may want to do it right. The would-be short 3-day noticed material event conforms SEC rule telegraphing some partnership(s). A telltale sign will be if an 8-K is filed on 2/1/17.
Mnkd may also choose to announce co-promoting 3rd party products such as synergistic DEXCOM CGM with some cash upfront and milestone based payments as Matt stated several times.
BTW, What madog365 refers to is called poison pill which Mnkd might need. Don't remember if Mnkd SH already voted upon creating one.
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Post by lakers on Jan 28, 2017 20:58:51 GMT -5
Lakers, I applaud you, but you are swimming against a very strong current, let's hope you're salmon enough to do it! You should add "and elusive enough not to be devoured by the hungry bears". This also applies to Mnkd.
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Post by lakers on Jan 28, 2017 12:18:56 GMT -5
1/27/17, Nate thinks a partnership or buy-in will happen. I'd agree with him. Let's see how much cash infusion will be. Is it possible we will get a Quad crown corporate event on Tues 2/1/17: EpiHale IND, EpiHale partnership, Afrezza regional partners, Major Buy-in ? Note that our CCO Castagna will also be present at the CC. MannKind Corporation (MNKD) (MNKD) will host a conference call to discuss Company developments [plural]at 5:00 PM (Eastern Time) on February 1, 2017. Presenting from the Company will be its Chief Executive Officer, Matthew Pfeffer and Chief Commercial Officer, Michael Castagna. Thus, it could be a multi-event one. Mgmt can't simply rehash what investors already knew from JPM 1/12/17. There must be new developments. That's why a Company development CC is held instead of simply Afrezza 3.0 change to internal sale force. I have a feeling a real, sustainable short squeeze tsunami is finally forming this year if those events happen. Consider this a Tsunami Warning. MannKind is moving forward with the filings required to sell Afrezza in a number of regions that essentially only require “FDA approval and some paperwork,” namely, Brazil, Canada, Mexico, Australia, MENA (Middle East and North Africa), UAE (United Arab Emirates), and it is also evaluating what would be required to gain approval in “Europe and other regions.” Of course, the company could simply be bluffing, but if they are not, this sort of language once again suggests that they feel much more confident that there will be money around to implement the plan than there might appear to be on first glance by an outsider.Along with its efforts to develop inhalable ephinephrine (efforts that include what the company has called a “successful” meeting with the FDA back in December), the company is moving forward with projects to develop inhalable treprostinil and palonosetron, with an eye towards eventually partnering those products once they are further along in the clinic.And, speaking of “the clinic,” I believe it is also worth noting that Matt also pointed out at JPM that MannKind is moving forward with plans to conduct pediatric, dosing, and time-in-range clinical trials with Afrezza. In addition, once the commercial(s) have been approved by the FDA (expected in the April time-frame, if I remember correctly), MannKind is planning to rollout its first direct-to-consumer (DTC) TV ads (in very targeted markets at first, mind you). As you might imagine, these clinical trials and TV ads will all require time, personnel, and, money to bring them to fruition… and, once again, these are all things that it would appear on a first glance that MannKind does not have at its disposal, but, reading between the lines, may have “lined up” after all, even if a partnership and/or buy-in (or perhaps even a wildly unexpected – by outsiders – ramp in Afrezza scripts?) that would provide additional capital hasn’t actually been announced/revealed yet.Read more: mnkd.proboards.com/thread/7115/nates-notes-new-article-out#ixzz4X4sGViR9
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Post by lakers on Jan 28, 2017 12:06:04 GMT -5
Excerpts follow.
Along with this news about hiring an in-house salesforce, we also learned that MannKind is moving forward with the filings required to sell Afrezza in a number of regions that essentially only require “FDA approval and some paperwork,” namely, Brazil, Canada, Mexico, Australia, MENA (Middle East and North Africa), UAE (United Arab Emirates), and it is also evaluating what would be required to gain approval in “Europe and other regions.” Of course, the company could simply be bluffing, but if they are not, this sort of language once again suggests that they feel much more confident that there will be money around to implement the plan than there might appear to be on first glance by an outsider (or in any one of a handful of persistently bearish blog articles you can read on a weekly basis!). Not only does the company appear to be moving forward with plans to grow sales of Afrezza in both the U.S. and abroad, it seems to be moving forward with other applications of the Technosphere platform at a slightly more aggressive pace than it was forced to take prior to the settlement with Sanofi (a turn of events that I want to remind you not only changed the financial position of the company by quite a bit, but also made it significantly easier for the company to start talking with other potential partners who may have been reluctant to get involved while Sanofi still had a tentacle involved in the story). Along with its efforts to develop inhalable ephinephrine (efforts that include what the company has called a “successful” meeting with the FDA back in December), the company is moving forward with projects to develop inhalable treprostinil and palonosetron, with an eye towards eventually partnering those products once they are further along in the clinic.
And, speaking of “the clinic,” I believe it is also worth noting that Matt also pointed out at JPM that MannKind is moving forward with plans to conduct pediatric, dosing, and time-in-range clinical trials with Afrezza. In addition, once the commercial(s) have been approved by the FDA (expected in the April time-frame, if I remember correctly), MannKind is planning to rollout its first direct-to-consumer (DTC) TV ads (in very targeted markets at first, mind you). As you might imagine, these clinical trials and TV ads will all require time, personnel, and, money to bring them to fruition… and, once again, these are all things that it would appear on a first glance that MannKind does not have at its disposal, but, reading between the lines, may have “lined up” after all, even if a partnership and/or buy-in (or perhaps even a wildly unexpected – by outsiders – ramp in Afrezza scripts?) that would provide additional capital hasn’t actually been announced/revealed yet.
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Post by lakers on Jan 28, 2017 11:42:16 GMT -5
MannKind ‘aggressively’ moving forward with inhalable epinephrine By Dan Stanton+ 16-Jan-2017 Last updated on 16-Jan-2017 at 14:37 GMT MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen. In January 2016, MannKind gave a positive spin to the news that Sanofi was pulling-out of its commercialisation partnership for the inhalable insulin product Afrezza by telling investors at the JP Morgan Healthcare Conference about the opportunities to regain and self-market its lead project, as well as investigate its proprietary Technosphere delivery platform with a number of candidates. A year on, and CEO Matthew Pfeffer told the same audience that within its pipeline, an epinephrine programme is “the only one that’s still moving forward aggressively,” and the firm had a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA) in early December to discuss clinical pathways for the anaphylaxis candidate. “That was a major step for us,” Pfeffer told delegates in San Francisco, and while he would not further details of the programme for now, he stressed the need to have “some alternatives in that space.” Epi-inhaler? Mylan’s EpiPen is the only epinephrine product available in the US, after Sanofi abandoned another marketing deal last year, this time with Kaleo for the Auvi Q injector. And a series of price hikes has led the US government to question the lack of competition and put pressure on the FDA to improve the generic drug review process. “Most of the technology [in developing] and existing products use auto-injector mechanisms,” Pfeffer said. “All too often, people are reluctant to either stab themselves in the leg with this rather scary looking needle or the cost of at $250 or $300 a pop unless they are really sure they need it, they don’t want to do that.” MannKind’s candidate will be a single-use disposable, he revealed. “It’s a simple couple of pieces of plastic, relatively affordable as you might imagine and we think it makes a nice alternative [to the EpiPen].” The handheld inhaler will comprise of the mouthpiece of the Afrezza inhaler with a cartridge built into it. Like Afrezza, ephinephrine will be delivered using MannKind’s Technosphere platform which uses the excipient fumaryl diketopiperazine (FDKP) – highly soluble at pH 6.0, the prevailing physiological pH in the lungs – in order to avoid both hepatic first pass metabolism and degradation in peripheral circulation in the delivery of an API. mobile.in-pharmatechnologist.com/Drug-Delivery/MannKind-aggressively-moving-forward-with-inhalable-epinephrine
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Post by lakers on Jan 27, 2017 15:18:50 GMT -5
On 12/13/16 Rose said, On the 11/9 call, our CMO stated that our current lead candidate is our inhaled epinephrine. With limited resources, we are focused on the clinical development program and post-marketing requirements for Afrezza and this lead candidate in the near term. As we’ve stated before, if there are partnering opportunities, we would announce them. You must appreciate that product candidates need to reach a level of value before any potential partner would be interested. We are focused on getting inhaled epi to that stage. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=17#ixzz4WzE2CRsXIt's EpiHale partnership most likely. Can anyone guess upfront cash effect vs pps? In my opinion upfront cash would need to be minimum $30-$50 million to move pps above $1. We could make a poll regarding how much cash upfront and the resulting pps 2-day after. Other variables are milestone bonus, royalty. I don't think Mnkd will take the P/L sharing route again. The partner must bear all trial cost and pay for Mnkd's COGS plus some margin. This should increase Danbury plant's utilization. It's beyond doubt that Mnkd can't afford to go alone. Expect IND to be filed this qtr and positive CRL a few weeks after IND. I've said all along, other TS drugs more likely save Afrezza first, not the other way around. Afrezza needs deep pocket, fully committed partners to be commercially successful.
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Post by lakers on Jan 27, 2017 13:08:24 GMT -5
On 12/13/16 Rose said, On the 11/9 call, our CMO stated that our current lead candidate is our inhaled epinephrine. With limited resources, we are focused on the clinical development program and post-marketing requirements for Afrezza and this lead candidate in the near term. As we’ve stated before, if there are partnering opportunities, we would announce them. You must appreciate that product candidates need to reach a level of value before any potential partner would be interested. We are focused on getting inhaled epi to that stage. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=17#ixzz4WzE2CRsXIt's EpiHale partnership most likely. Can anyone guess upfront cash effect vs pps?
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Post by lakers on Jan 27, 2017 12:50:34 GMT -5
Fiscal Quarter EndDec 2015 Date Reported03/14/2016 4Q16 ER on 2/1/17 is unusually early. I expect good news. EpiHale IND, partner with cash upfront? Ex-US updates? its not earnings report. its a call on company developments. I still expect good news. EpiHale IND, partner with cash upfront.
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Post by lakers on Jan 27, 2017 12:44:22 GMT -5
Fiscal Quarter EndDec 2015
Date Reported03/14/2016
4Q16 ER on 2/1/17 is unusually early. I expect good news. EpiHale IND, partner with cash upfront? Ex-US updates?
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Post by lakers on Jan 20, 2017 18:58:56 GMT -5
SAN DIEGO, Jan. 19, 2017 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Company” or “Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis. Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”). The FDA indicated that it considered the resubmission to be a complete response to the CRL. About the Product Adamis’ EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (PFS) was designed as a lower cost alternative to market leading auto-injectors. Adamis’ PFS provides a single-dose of epinephrine, which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, foods (such as nuts), drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis. About Anaphylaxis Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. According to information published by industry sources reporting on findings from a 2009-2010 study, up to 8% of U.S. children under the age of 18 have a food allergy, and approximately 38% of those with a food allergy have a history of severe reactions. Anaphylaxis requires immediately medical treatment, including an injection of epinephrine. The number of prescriptions for epinephrine products has grown annually, as the risk of anaphylaxis has become more widely understood. Based on industry data, Adamis estimates that sales of prescription epinephrine products in 2015 were approximately $1.2 billion.globenewswire.com/news-release/2017/01/19/909333/0/en/Adamis-Pharmaceuticals-Announces-FDA-Acceptance-of-Resubmission-of-Its-Epinephrine-Pre-Filled-Syringe-NDA.html
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Post by lakers on Jan 14, 2017 12:27:46 GMT -5
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Post by lakers on Jan 13, 2017 1:45:20 GMT -5
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