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Post by peppy on Apr 8, 2022 14:17:46 GMT -5
Peppy, UTHR announced the findings before the open on April 6, and has been up every day since. MNKD has been down every day since. I understand what you meant to say now. The announcement was the publishing of the findings correct? Turns out after peer review the publishing is important. I learned this stuff from listening to the papers presented on TWIV, regarding the publishing. |
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Post by mymann on Apr 8, 2022 19:46:01 GMT -5
We should start a poll if Tyvaso dpi get fda approval or further delay by FDA. Starting to feel it's going to be delayed again after reading the opinions of our proboard people.
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Post by sellhighdrinklow on Apr 8, 2022 21:52:15 GMT -5
7 to 10 years ago AL Mann had a beef w a Wallstreet dude at an annual shareholders meeting or similar. Who was the person that Al had the issue with and therefore kicked him out of the meeting? Maybe this Wallstreet person is who is orchestrating ($$$ greasing FDA palms!!)0 the FDA's CONTINUOUS delays w Mannkind actually becoming a prosperous biotechnology company?. 100% serious here.
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Post by bones1026 on Apr 8, 2022 22:25:24 GMT -5
7 to 10 years ago AL Mann had a beef w a Wallstreet dude at an annual shareholders meeting or similar. Who was the person that Al had the issue with and therefore kicked him out of the meeting? Maybe this Wallstreet person is who is orchestrating ($$$ greasing FDA palms!!)0 the FDA's CONTINUOUS delays w Mannkind actually becoming a prosperous biotechnology company?. 100% serious here. [b Martin Shrkeli. Who sits in prison. |
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Post by anderson on Apr 8, 2022 23:58:46 GMT -5
We should start a poll if Tyvaso dpi get fda approval or further delay by FDA. Starting to feel it's going to be delayed again after reading the opinions of our proboard people. Sounds like a good idea. I am hoping for the best but preparing myself for the worst. MNKD needs to shake its bad luck(maybe curse is a better word). Still think Afrezza only got approved because the FDA didn't want to go against unanimous consent of the advisory panel. It was to public and would have exposed their bias. Not sure how Al got them to agree to the panel in the first place. If they delay Tyvaso DPI again, Martine needs to figure out how to get it before an advisory panel. |
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Post by Deleted on Apr 9, 2022 11:20:00 GMT -5
Peppy, UTHR announced the findings before the open on April 6, and has been up every day since. MNKD has been down every day since. The market can manipulate MNKD easier than UTHR. MNKD has a large Retail Base that can get scared very easily and it only takes a small Bear Raid to get Reets running for the streets. This is the time to keep some powder dry and pounce when the stock drops hard in a short period of time. I expect the stock to fall a little further until the 3rd week in April and then it will start climbing into May approval. |
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Post by stockwhisperer on Apr 9, 2022 18:55:06 GMT -5
endpts.com/when-a-citizen-petition-works-fdas-review-of-united-therapeutics-pah-drug-extended-to-may/Do not understand why the FDA bothered to say what they said in the CRL unless they are going to stand behind it. They certainly did not have to say those things that pointed to no black box warning and only one deficiency - relating to a third-party facility, preventing an FDA approval. What really changed - the CP was out there for some time before the CRL. Why the FDA went on to delay a decision based on the CP makes no sense. What was new in the CP that the FDA did not already know about or would not have already thought about on their own, prior to the CRL? Makes you wonder, who’s on first. Are there totally different people deciding about the CP vs the final overall FDA decision? If so, might they talk prior to putting out the CRL? Seems there is some kind of breakdown in their processes - most certainly the area of communication. Lassman seems to be a well known, respected lawyer. Seems political - seems UTHR & MNKD would have similar questions & concerns. In any case, while quite the head scratcher, I do not expect a further delay but we will see.
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Post by lakon on Apr 10, 2022 10:17:16 GMT -5
1. Better for a bureaucrat to say no, review the petition for merit, then, say yes/no for CYA purposes.
2. Better to buy time to evaluate which way the wind is blowing to profit from this CP...
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Post by stockwhisperer on Apr 10, 2022 12:25:49 GMT -5
Absolutely, CPs should indeed be reviewed for merit - imo… in a timely manner and in the correct order. If the FDA does not know enough about what they are doing, in that the CP alerts them to new things they could not - would not think of on their own, they should at least think about what they are saying & releasing in a CRL and plan on standing behind those words - regardless, once it is released. The CP had already been sitting out there for some time prior to the CRL. Why would the FDA mention the label - implying no black box warning unless they knew enough to say it. Same for the FDA saying there was only 1 discrepancy standing between approval. They could have simply explained that, while there was only 1 discrepancy at that moment, the CP was still open and pending further investigation. Upon satisfactory resolution of the discrepancy and completion of the CP investigation, the FDA decision would be made by X. Seems too simple. Hope the concept is correct - that the FDA knew exactly what they were doing and saying in the CRL and that they do plan to stand behind it.
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Post by prcgorman2 on Apr 10, 2022 12:40:19 GMT -5
I assume the CP review (by lawyers) is a different process with different timeline (generally) than that of the NDA review by technocrats. I assume the bureau is heavy on technocrats and light (relatively) on attorneys working CPs. It may be the only point the two processes have in common is final(?) resolution of an NDA. The FDA is beholden to Congress and there are statutory requirements for expedient delivery of results, so my guess is NDA processes and timelines are the key drivers for the May ETA for UTHR’s Tyvaso DPI.
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Post by sayhey24 on Apr 11, 2022 10:08:48 GMT -5
endpts.com/when-a-citizen-petition-works-fdas-review-of-united-therapeutics-pah-drug-extended-to-may/Do not understand why the FDA bothered to say what they said in the CRL unless they are going to stand behind it. They certainly did not have to say those things that pointed to no black box warning and only one deficiency - relating to a third-party facility, preventing an FDA approval. What really changed - the CP was out there for some time before the CRL. Why the FDA went on to delay a decision based on the CP makes no sense. What was new in the CP that the FDA did not already know about or would not have already thought about on their own, prior to the CRL? Makes you wonder, who’s on first. Are there totally different people deciding about the CP vs the final overall FDA decision? If so, might they talk prior to putting out the CRL? Seems there is some kind of breakdown in their processes - most certainly the area of communication. Lassman seems to be a well known, respected lawyer. Seems political - seems UTHR & MNKD would have similar questions & concerns. In any case, while quite the head scratcher, I do not expect a further delay but we will see. What changed was word got out that Tyvaso DPI was not going to have a black box warning. If Tyvaso DPI has no warning why should afrezza? There is an entire industry which has been doing everything they can to suppress afrezza. One huge thing they have had on their side is the black box. My guess is someone from "the industry" contacted the FDA and raised the CP issue when the indication was no black box. The FDA had to respond to this and did so by asking for additional safety data. UTHR/MNKD were prepared for this request and sent a dump truck full of data which was more than the FDA could digest in a few days. I don't think the industry cares whether Tyvaso DPI has a black box or not but they sure do care if it provides a precedence for afrezza. We should know soon. UTHR has trended up since February. |
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Post by peppy on Apr 12, 2022 10:04:05 GMT -5
endpts.com/when-a-citizen-petition-works-fdas-review-of-united-therapeutics-pah-drug-extended-to-may/Do not understand why the FDA bothered to say what they said in the CRL unless they are going to stand behind it. They certainly did not have to say those things that pointed to no black box warning and only one deficiency - relating to a third-party facility, preventing an FDA approval. What really changed - the CP was out there for some time before the CRL. Why the FDA went on to delay a decision based on the CP makes no sense. What was new in the CP that the FDA did not already know about or would not have already thought about on their own, prior to the CRL? Makes you wonder, who’s on first. Are there totally different people deciding about the CP vs the final overall FDA decision? If so, might they talk prior to putting out the CRL? Seems there is some kind of breakdown in their processes - most certainly the area of communication. Lassman seems to be a well known, respected lawyer. Seems political - seems UTHR & MNKD would have similar questions & concerns. In any case, while quite the head scratcher, I do not expect a further delay but we will see. If Tyvaso DPI has no warning why should afrezza? There is an entire industry which has been doing everything they can to suppress afrezza. One huge thing they have had on their side is the black box. My guess is someone from "the industry" contacted the FDA and raised the CP issue when the indication was no black box. The FDA had to respond to this and did so by asking for additional safety data. UTHR/MNKD were prepared for this request and sent a dump truck full of data which was more than the FDA could digest in a few days. I don't think the industry cares whether Tyvaso DPI has a black box or not but they sure do care if it provides a precedence for afrezza. We should know soon. UTHR has trended up since February. Point well taken. "What changed was word got out that Tyvaso DPI was not going to have a black box warning." revelation.... disclosure to humans of something relating to human existence or the world. |
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Post by harryx1 on Apr 12, 2022 12:22:25 GMT -5
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Post by mango on Apr 12, 2022 12:34:53 GMT -5
The hypocritical irony of all this is starting to come to light. We are dealing with an FDA approved drug and excipient that has a solid and proven safety profile from years of preclinical, clinical and post marketing safety data. No indications of bronchospasm and the only cases that were were indeed from poorly uncontrolled asthmatics.
Add in a new drug with same excipient, but this time with patients who have one of the worst chronic lung conditions, where zero incidence of bronchospasm occurred. Simply mind-boggling, eh? Wrong. Simply common sense. Bronchospasm will always be a concern with people who have a chronic lung disease, especially asthma, but even more especially UNCONTROLLED asthma. Even albuterol can cause bronchospasm. This should have never been an issue but the ignorant folks over at FDA made it into one.
In a just and perfect world, this CP would backfire resulting in a complete audit of Afrezza clinical trial with the uncontrolled asthmatics, all FDKP data and a completely revised Afrezza label with no Black Box Warning, along with a fully approved Tyvaso DPI with no warnings, and lastly an apology letter to MannKind.
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Post by cedafuntennis on Apr 13, 2022 12:57:07 GMT -5
Be careful what you wish for. With the perceived corruption in the FDA, they may put a hold on all these drugs for 2 years till they force such an evaluation... I would not put it past them considering that the fox pays for guarding the chicken coop.
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