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Post by hellodolly on Feb 24, 2022 6:08:00 GMT -5
WESTLAKE VILLAGE, Calif. and DANBURY, Conn., Feb. 24, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, was informed that the U.S. Food and Drug Administration (FDA) issued an information request to United Therapeutics Corporation earlier this month regarding the New Drug Application (NDA) for Tyvaso DPI, requesting additional information regarding the pulmonary safety of Tyvaso DPI related to a pending Citizen Petition. United Therapeutics promptly responded to the agency’s request. MannKind has now learned that the FDA considers the response to be a major amendment to the NDA, thereby extending to May 2022 the FDA’s deadline to complete its review of the pending NDA.
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Post by liane on Feb 24, 2022 6:31:25 GMT -5
This is just WRONG! I've put up with a lot, but this takes the cake at the FDA.
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Post by hellodolly on Feb 24, 2022 6:44:21 GMT -5
This is just WRONG! I've put up with a lot, but this takes the cake at the FDA. I just don't see what additional information UTHR could have sent to the FDA that wouldn't have already been sent with the original application. Drug safety profiles aren't they part of the original submission? The good news, nothing has been rejected and the information has already been in the hands of the FDA. We could hear before May, 22, 2022. |
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Post by nxc2 on Feb 24, 2022 6:48:47 GMT -5
While this is not good in short term, hoping this will put the lung issue to rest for all future applications.
Trying to look on bright side.
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Post by jkendra on Feb 24, 2022 7:00:53 GMT -5
I would have to imagine this looks blatantly obvious to everyone. Bold move especially since there are so many eyes on this.
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Post by Chris-C on Feb 24, 2022 7:12:35 GMT -5
The FDA essentially tipped off this latest bit of BS in their earlier CRL when they mentioned that they had not evaluated the Citizen’s Petition. But why classify the issue as a Class I review then?
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Post by prcgorman2 on Feb 24, 2022 7:23:41 GMT -5
The FDA essentially tipped off this latest bit of BS in their earlier CRL when they mentioned that they had not evaluated the Citizen’s Petition. But why classify the issue as a Class I review then? “Major” addendum in the NDA. Now a Class II review?  |
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Post by mango on Feb 24, 2022 7:28:04 GMT -5
This is such BS. This Citizen Petition is a clear anti-competitive strategy against the approval of Tyvaso DPI. We should challenge the same kind of Citizen Petition against Liquidia, as we all know they don’t have the extensive pulmonary safety data like MannKind does.
What does this part mean about amendment? “MannKind has now learned that the FDA considers the response to be a major amendment to the NDA”
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Post by stockwhisperer on Feb 24, 2022 7:34:52 GMT -5
Unbelievable that the FDA needs a citizens petition to alert them to what might be needed for an approval. Just makes no sense.
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Post by akemp3000 on Feb 24, 2022 7:45:27 GMT -5
The citizen's petition is a convenient excuse for corruption. It was likely planned and funded by BP. The drug has been widely used for years and the drug delivery is arguably once of the most tested ever. First thought is that this is unbelievable but then again it's really not. This is the corrupt political world we currently live in.
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Post by jkendra on Feb 24, 2022 7:53:13 GMT -5
The citizen's petition is a convenient excuse for corruption and was likely funded and planned by BP. The drug has been widely used for years and the drug delivery is arguably once of the most tested ever. First thought is that this is unbelievable but then again it's really not. This is the corrupt political world we currently live in. Does a panel vote on this decision ? |
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Post by anderson on Feb 24, 2022 7:54:01 GMT -5
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bkdmd
Researcher
Posts: 79
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Post by bkdmd on Feb 24, 2022 7:54:21 GMT -5
Like I said yesterday.
after all of these years and years..... Here we go again.
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Post by Chris-C on Feb 24, 2022 8:02:30 GMT -5
Like I said yesterday. after all of these years and years..... Here we go again. Torture by a thousand small cuts. I bet Martine is furious about the $105M UTHR essentially wasted on an expedited review for Tyvaso DPI. I certainly would be…especially because FDA seems to be continuously moving the goal post. |
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Post by sportsrancho on Feb 24, 2022 8:05:30 GMT -5
Cash is king right now. This blood bath could go on for quite a while.
Luckily I sold all my travel stocks yesterday.
I’ll be back nibbling much lower.
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