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Post by cretin11 on Feb 25, 2022 14:39:37 GMT -5
There is too much good news going on. 2 years from now this stock will be, well, very much higher than it is right now. This price is a screaming steal. I just hope it holds for awhile while I work on getting more cash available to buy some more. It will probably take me til next Thursday to get it tranferred. I predict you'll have more than enough time to add shares in this price range (or lower). Hoping to be wrong. Yesterday was bad on a few levels, there's nothing imminent to spark a quick reversal. |
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Post by ptass on Feb 25, 2022 14:46:45 GMT -5
I'm on the fence regarding the delay. Did the FDA ask about the safety and almost immediately recieve 500 page report. Causing them to say "S#!t" we need time to review this dissertation. Or did they plan this all along.
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Post by mango on Feb 25, 2022 15:02:05 GMT -5
This is grounds for what triggers a major amendment to the NDA Submission of a major amendment to an original NDA, efficacy supplement, or resubmission of an NDA or efficacy supplement within 3 months of the end of the initial review cycle constitutes an agreement by the applicant under section 505(c) of the Federal Food, Drug, and Cosmetic Act to extend the initial review www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-B/section-314.60Like Mike said, we have 20 years of FDKP data. There has been zero safety signals in preclinical, clinical and post market data. 5 people with asthma in Afrezza clinical trials developed bronchospasm. It should have never warranted the shenanigans we have been put through. The fact that Tyvaso DPI was used safely in people with chronic lung disease, PAH, and none developed bronchospasm tells you all you really need to know. Asthma and PAH are two different diseases. A person with asthma can develop bronchospasm from inhaling literally any foreign matter. I guarantee that if you gave 20 people with asthma Yutrepia, some would develop bronchospasm. You could also give 20 people with asthma Afrezza right now and have them take all the precautions like drinking water before and after and proper inhalation technique and there’s a possibility none will develop bronchospasm. The fact FDA made such a big deal about this, while contrarily just approving a drug for Alzheimer’s with no clinical value just goes to show you how inept the agency really is. |
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Post by sayhey24 on Feb 25, 2022 15:04:48 GMT -5
Yet the FDA didn't have a single question about LQDA's excipient and are 100% fine with 2 weeks of safety testing!?!?!??!?!? The whole situation reeks to me, the FDA received the citizens petition Jul 8th 2021, issued the CRL Oct 15th 2021 and stated it had not looked at the CP yet. WTF!?!?!?!? Then sent a letter Jan 4th 2022 to the ambulance chasing lawyer stating that they have not yet resolved the issues he raised in the CP. All the while telling UTHR that they would have a decision in Feb. IMO it was a planned stall tactic by the person in charge of the Tyvaso DPI case to delay as long as possible since they are either being paid off, blackmailed or related to someone at LQDA or a hedge fund. JMHO. IMO you could not be more RIGHT!!!! Something really shitty has happened!! I can't put my finger on it... Or say exactly what... I JUST KNOW IT!! I don't think anything has happened. Its rinse and repeat. Its anything to delay afrezza progress. Afrezza is a very dangerous drug to the diabetes industry and the diabetes industry is really big business. By not placing a black box warning on Tyvaso DPI it further justifies not having one on afrezza. When Tyvaso DPI got delayed a lot of the discussion was around the draft label and that it did not include the same black box as afrezza which made it a very public issue. I think its that simple and it was probably front and center during the FDA review board review as a result of BP pressure. IMO afrezza is close to finally breaking out. The CGM has saved afrezza! Without it afrezza was doomed. With Mike now starting to leverage the CGM and all these diet companies starting to leverage CGMs, pretty soon GPs will have no choice. They are going to have patients walking through the door with a Libre on their arm held in place with a Nutrisense patch and the patients are going to know more than their doctor about their diet and how it effecting their BG levels. When the GP starts talking A1C and the patient has their AGP in hand and corresponding food history, the GP is going to get laughed at. Mike's "Seeing is Believing" campaign is a great first step of poking these GPs in the eye and lets be clear, these GPs are now big corporations who have hired 100's of doctors. The GP is no longer Dr. Welby running his own office. Without the CGM these guys would continue to hide behind A1C and continue to push pills which do nothing to address the first and most important issue the PWDs have and thats post prandial glucose excursions. The CGMs see it and track it and only afrezza can stop the excursion. Diet's nice but will only get the Levels and nutrisense and veri so far. |
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Post by sweedee79 on Feb 25, 2022 15:49:55 GMT -5
sayhey24Something did happen.. But your words are the voice of reason and I've always appreciated that. I'm just not so sure that this is the last of it. I hope so...
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Post by cretin11 on Feb 25, 2022 16:00:16 GMT -5
IMO you could not be more RIGHT!!!! Something really shitty has happened!! I can't put my finger on it... Or say exactly what... I JUST KNOW IT!! I don't think anything has happened. Its rinse and repeat. Its anything to delay afrezza progress. Afrezza is a very dangerous drug to the diabetes industry and the diabetes industry is really big business. IMO afrezza is close to finally breaking out. The CGM has saved afrezza! Without it afrezza was doomed. With Mike now starting to leverage the CGM and all these diet companies starting to leverage CGMs, pretty soon GPs will have no choice. They are going to have patients walking through the door with a Libre on their arm held in place with a Nutrisense patch and the patients are going to know more than their doctor about their diet and how it effecting their BG levels. When the GP starts talking A1C and the patient has their AGP in hand and corresponding food history, the GP is going to get laughed at. sayhey i hope you're right about Afrezza finally breaking out. Our NRx count is identical to what it was in Sept 2017. How do you quantify "breaking out" in terms of NRx and/or TRx? 5000, 10,000? (Those numbers would be noteworthy IMO and worthy of "break out" terminology at least for starters.) What's your estimated time frame for us to get into those ranges? |
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Post by castlerockchris on Feb 25, 2022 19:19:33 GMT -5
I'm out!!! It's been over a decade of this.. and it doesn't seem to get better.... All that I saw in both calls was someone trying to calm the storm...I'm off to find something better.. I am partially in your camp Sweedee. Some of you may remember my post (more like rant) back in October of how tired I was at the "can constantly being kicked down the road" when it comes to MNKD. At that time I said if it happens one more time I will be lightening up my position. As hard as this is going to be, because it will be admitting my decade plus investment thesis was not entirely correct, I am going to unwind a portion of our MNKD position starting next week. While I believe Tyvaso DPI will be approved, I can't help but wonder what the next excuse/reason for things not progressing the way everyone projected will be. Mike already said on the conference call there are supply chain issues, chip shortages in particular, with building BluHale. I thought I read that UTHR is counting on BluHale as an integral part of their launch. Will that be the next thing that makes things "not go as planned?" It is sad that MNKD and its partners can't seem to execute or accurately forecast outcomes. They seem genuinely surprised when things don't go their way. We can blame it on the inept, overly bureaucratic, incompetent FDA (I am not willing to call it corrupt). Or on the collusion of shorts, or BP. It doesn't matter what the reason, MNKD can't seem to catch a break. I give MNKD credit for delivering on a lot over the last couple of years. I do believe the UTHR collaboration was a watershed moment for the company. I do believe their pipe line has promise, but most of those products are one to two years into the future and fraught with just as many road blocks and speed bumps as Afrezza and Tyvaso DPI have been. I am not abandoning ship, just reducing my risk while at the same time holding a good chunk of upside. Here is to hoping I am very wrong and that selling a portion of our shares is the worst trade I ever make. |
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Post by sayhey24 on Feb 25, 2022 20:11:22 GMT -5
I don't think anything has happened. Its rinse and repeat. Its anything to delay afrezza progress. Afrezza is a very dangerous drug to the diabetes industry and the diabetes industry is really big business. IMO afrezza is close to finally breaking out. The CGM has saved afrezza! Without it afrezza was doomed. With Mike now starting to leverage the CGM and all these diet companies starting to leverage CGMs, pretty soon GPs will have no choice. They are going to have patients walking through the door with a Libre on their arm held in place with a Nutrisense patch and the patients are going to know more than their doctor about their diet and how it effecting their BG levels. When the GP starts talking A1C and the patient has their AGP in hand and corresponding food history, the GP is going to get laughed at. sayhey i hope you're right about Afrezza finally breaking out. Our NRx count is identical to what it was in Sept 2017. How do you quantify "breaking out" in terms of NRx and/or TRx? 5000, 10,000? (Those numbers would be noteworthy IMO and worthy of "break out" terminology at least for starters.) What's your estimated time frame for us to get into those ranges? over 30 million T2s in the U.S. Only god knows how many prediabetics. 10,000+ by the end of 2024 assuming Mike really pushes hard the "Seeing is Believing" campaign and starts getting some large medical corporations on board. Geisinger in NE Pa is a good example and have so many T2's. Partnering with some of these diet companies who can only do so much with diet alone wouldn't be a bad idea either. These companies are getting a couple hundred a month cash to monitor a CGM and have a nutritionist give tele-advice. Whats another $100 per month cash to these people if they are seeing real results with BG control and can still have the coke and eat the pizza once in awhile. If Mike can demonstrate with these companies and the "Geisingers" stopping T2 progression and he should be able to then we have a new ball game and side stepped the ADA and the SoC. I wouldn't mind Mike taking his "Seeing is Believing" to a TV commercial. I see Dexcom commercials all the time. At the same time the T1 kids will be approved which will start moving afrezza into the T1 market but there is only 4 million in that market. |
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Post by mytakeonit on Feb 25, 2022 20:58:30 GMT -5
People always talk about kids. If they see a sickly kid doing well on Afrezza ... I'm sure the grown ups will be talking about it.
But, that's mytakeonit
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Post by radgray68 on Feb 25, 2022 21:03:23 GMT -5
I'm staying. After over 6 years of trading the stock, and man have I been working it, I've finally accumulated a position twice the size of anything I could have before the ADCOM. I did alright then and I think I'll do alright when this does turn the corner...again. I can still easily see over $1 a share in earnings by 2027. Slap whatever P/E ratio you want to that and it's a hell of a lot better than $2. freakin 72 a share. Heck, even during the worst of our debt spiraling, the banks still gave us money at $6 a share. That has to account for something when considering the overall valuation of the company. Even if we're just a manufacturing and royalty machine by then. Good luck to all of you. It's disheartening, of late, I know. I guess I'm staying in mostly because I'm stubborn but I'm also working for the next 5 years anyway, and I don't (knock on wood) NEED the money right now, thank heavens, so I'm lucky in that respect. What an eye-opening experience this has been. It's like we're trying to break into the drug business or something.  |
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Post by mango on Feb 25, 2022 22:08:16 GMT -5
FDA is pulling shenanigans no doubt. We are seeing it everywhere though and not just with us. They’re pulling it with not wanting to disclose the vaccine data for 50+ whatever years, approving Alzheimer’s drug that doesn’t have clinical value and is dangerous, and now this.
What I do know is we have 20 years of FDKP data and it’s safe. We have one of the best looking FDAERS rap sheets out there too. People aren’t reporting lung issues or bronchospasm with Afrezza. Kendall did the study showing injectable insulin has similar lung function decline and it’s reversible with Afrezza when stopped if there is any.
This is a small set back in the grand scheme of things, in Tyvaso DPI lifetime this set back is nothing. We have a bright future ahead of us with a serious pipeline developing. Mike isn’t putting up BS pipeline assets, we have some really unique assets on the board addressing rare diseases. Pay attention to how Mike talks about Clofazimine, he is super excited every single time.
If everything went easy for us we’d never get the full experience. We have the passion, patience and persistence. We’ll get there.
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Post by cretin11 on Feb 25, 2022 22:56:13 GMT -5
sayhey your mark of 10,000 scripts per week by end of 2024 seems reasonable, if leadership does the things you suggest. That’s a huge if. Wish I had confidence in that execution. But I don’t foresee us getting new leadership soon, and I’m stubborn enough (and believe in the technology) to stick around and hope for a 180 turnaround in performance. Or more likely, for Martine to get Tyvaso off the ground in which case we should at least see some share price appreciation.
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Post by prcgorman2 on Feb 25, 2022 23:49:27 GMT -5
I'm on the fence regarding the delay. Did the FDA ask about the safety and almost immediately recieve 500 page report. Causing them to say "S#!t" we need time to review this dissertation. Or did they plan this all along. I had the same thought, but I have worked with a number of federal regulators (not the FDA) over some years time and my experience has been they are US government employees doing their job to the best of their ability just like any of us do in our jobs. Most I’ve worked with are lawyers. And, when presented with deeply technical material, they engage technologists. Since it was an attorney that presented the petition, it would be FDA attorneys that got the task of dealing with it, and then they would engage agency technologists to assist as needed. Five hundred pages of material is a lot of material and there is going to be time needed to determine if it is all relevant to, and adequately addresses, any or all of the concerns in the petition. 90 days goes by in a flash if you’re working on something meaty so if it is all on the up and up, the delay is understandable, and reasonable, and since the great majority of these petitions get dismissed for what they are, there is reason to be hopeful. Regardless, I can’t help feeling burned by Mannkind’s earlier experiences and worried that “here we go again”. For everyone’s sake, I hope it is the normal case and we can all breathe a sigh of relief in May. In order to sleep better, I unwound a portion of my position. It is not lost on me that the price per share is greatly improved for adding, and may improve more for that purpose, so I will monitor and may re-add. |
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Post by sayhey24 on Feb 26, 2022 10:59:43 GMT -5
I'm on the fence regarding the delay. Did the FDA ask about the safety and almost immediately recieve 500 page report. Causing them to say "S#!t" we need time to review this dissertation. Or did they plan this all along. I had the same thought, but I have worked with a number of federal regulators (not the FDA) over some years time and my experience has been they are US government employees doing their job to the best of their ability just like any of us do in our jobs. Most I’ve worked with are lawyers. And, when presented with deeply technical material, they engage technologists. Since it was an attorney that presented the petition, it would be FDA attorneys that got the task of dealing with it, and then they would engage agency technologists to assist as needed. Five hundred pages of material is a lot of material and there is going to be time needed to determine if it is all relevant to, and adequately addresses, any or all of the concerns in the petition. 90 days goes by in a flash if you’re working on something meaty so if it is all on the up and up, the delay is understandable, and reasonable, and since the great majority of these petitions get dismissed for what they are, there is reason to be hopeful. Regardless, I can’t help feeling burned by Mannkind’s earlier experiences and worried that “here we go again”. For everyone’s sake, I hope it is the normal case and we can all breathe a sigh of relief in May. In order to sleep better, I unwound a portion of my position. It is not lost on me that the price per share is greatly improved for adding, and may improve more for that purpose, so I will monitor and may re-add. I fully agree on everything you said until you couldn't sleep and unwound your position. I have held steady for a long time in MNKD but I see this as an opportunity so I was a buyer. I don't know which group in the FDA made the call since Tyvaso DPI would be considered a drug/device combo. But to your point about lawyers. The guy who heads up the device division is a lawyer/doctor. His wife is a lawyer. Their friends are all lawyers and lawyers in these positions want risk AVOIDANCE. I can see the 500+ page response and Jeff asking the review team what dp they think and their response being it will take months to catalog this stuff. I think Mr. Shuren is on the up and up but he has a job to do and he will do it fairly. www.fda.gov/about-fda/cdrh-offices/office-center-directorI don't know if Martine understands the world she entered when she partnered with MNKD. She probably does but Al underestimated the fight MNKD would get. I hope she is not underestimating things. IMO, this is much different than the days of Martin. When Peggy was running the FDA her husband Pete Brown was running the Hedge Fund. Was Martin involved with Pete? IDK but I would not be surprised. With that said and as much as most of us hate Martin, MNKD screwed up. There was an FDA device requirement for testing which MNKD did not do it. They could have done a small quick study for CRL 2 submission but they went on the FDA's wink and nod that they will get a pass. Man, if I was Pete and wanted to be CEO of that Hedge Fund and make a $ton I can't blame him for pulling that lever. At the same time it was a killer for MNKD but it was clearly a risk Al took and IMO Al never appreciated the resistance he was going to face from the diabetes industry. I hope I am right and if so May will be a great month and I will be looking forward to the annual meeting in Danbury. |
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Post by winner on Feb 26, 2022 15:44:00 GMT -5
Excerpt from another forum and I quote:
"an IR is a letter sent to an applicant during an
application assessment to request further information or a clarification of the information already provided that is needed or would be helpful to allow completion of the discipline assessment. FDA does not consider IRs to be CRLs because IRs, like DRLs, do not represent a complete
assessment of the entire application and therefore do not stop the assessment clock. As with DRLs, an IR does not necessarily reflect input from all supervisory levels. "
"Furthermore, an applicant’s response to an IR or DRL generally will not be classified as a major or minor amendment and will not affect the assessment clock. However, if a response to an IR or a DRL contains either information not requested by FDA or information that requires a more thorough assessment as determined by FDA, FDA will classify the submission as an amendment and assign an appropriate new goal date for that amendment"
fda.gov/media/109915/download
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