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Post by otherottawaguy on Feb 24, 2022 10:21:44 GMT -5
Is there a way of submitting a Citizen's Petition on LQDA?
OOG
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Post by markado on Feb 24, 2022 10:22:45 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. I wish it would "put the lung issue to rest," but I think it more likely to generate a per-application, API+FDPK, safety standard precedent. Approvals may be conditioned on reasonably sized long term studies pertaining to lung health, functionality and capacity while on any inhalable med. This will raise dev costs per drug, but not deter larger-scaling advancements. What it may deter are smaller dollar smaller population meds, but TBD. This is just an opinion based on the tea leaves, to date. |
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Post by sweedee79 on Feb 24, 2022 10:27:23 GMT -5
I disagree... I've been watching both lqda and Mnkd price action and goings on for months now... It has always been my opinion that lqda is behind the citizens petition... In just the past months I became aware that Roger Jeff's was Co CEO of UTHR with Martine.. and now CEO of Lqda... It's pretty obvious that Martine and Jeff's are at war.. and I have NO DOUBT that lqda is doing everything they can to stop us from going to market first and that Jeff's has personal knowledge, and is also a scientist and a smart one who knows how to work the FDA... I have no doubt!!! Wish I would have followed my gut months ago!!! It's naive to think this is all just innocent!! Exactly. Delay gives LQDA exactly what it wants, but don't think that Martine is not aware of that. I'd love to be the fly on the wall for internal conversations on how to beat LQDA at their own game. I think it was Martine who tried to delay them in the first place with the IP litigation... So I'm not so sure who started the game or what is going on... What is clear to me is that Martine and Roger Jeff's had a falling out many years ago and from what I've gathered Jeff's had just as much to do with building UTHR the company, as Martine did... They are both very smart... And we have reason to be concerned!!! Jeff's wants to win. |
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Post by sweedee79 on Feb 24, 2022 10:39:45 GMT -5
Is there a way of submitting a Citizen's Petition on LQDA? OOG From what I understand anyone can... Just go to lawyer.. you can even remain anonymous.... But you need the knowledge and the science so you can feed things to the FDA while you hide behind a lawyer. |
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Post by stockwhisperer on Feb 24, 2022 10:43:13 GMT -5
Don’t forget politics, deep pockets & corruption… of course none of that applies.
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Post by wyattdog on Feb 24, 2022 10:58:11 GMT -5
Dr. Rothblatt speaking on today’s uthr conference call. “ our super convenient tyvaso dpi product remains well positioned for its may 2022 launch. The fda did just delay it’s approval decision from this month to may but that 3 month delay is not important compared to the products block buster revenue potential and patent life well into the 2030’s. Three month delay to start on a billion dollar revenue trajectory is no big deal.” This starts at 6:25 on the conference call
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Post by akemp3000 on Feb 24, 2022 11:04:35 GMT -5
"The FDA receives about 200 citizen petitions annually. Nearly every time a biopharma company or its law firm files a citizen petition to delay a new or generic drug’s approval, the petition is shot down with a quick explanation from the FDA. Research shows more than 90% of these petitions are ultimately rejected by the FDA, particularly as many are only filed with the intention of delaying an approval."
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Post by mcbone on Feb 24, 2022 11:12:02 GMT -5
Yep, that's what I am saying. This particular petition is probably better written than most, but it's still likely to be dismissed for what it obviously is - an attempt by LQDA to delay Tyvaso DPI. The FDA is slow but not stupid.
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Post by awesomo on Feb 24, 2022 11:14:10 GMT -5
Yep, that's what I am saying. This particular petition is probably better written than most, but it's still likely to be dismissed for what it obviously is - an attempt by LQDA to delay Tyvaso DPI. The FDA is slow but not stupid. It’s not an attempt to delay anymore, it’s already been successful in that. Again, I ask, what is stopping the FDA from delaying again in May? |
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Post by Chris-C on Feb 24, 2022 11:30:25 GMT -5
Yep, that's what I am saying. This particular petition is probably better written than most, but it's still likely to be dismissed for what it obviously is - an attempt by LQDA to delay Tyvaso DPI. The FDA is slow but not stupid. If an investor were to write to LQDA investor relations and ask specifically if LQDA was behind the citizen's petition filed against Tyvaso DPI, would they deny it or simply refuse to comment? |
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Post by mcbone on Feb 24, 2022 11:39:27 GMT -5
Yep, that's what I am saying. This particular petition is probably better written than most, but it's still likely to be dismissed for what it obviously is - an attempt by LQDA to delay Tyvaso DPI. The FDA is slow but not stupid. It’s not an attempt to delay anymore, it’s already been successful in that. Again, I ask, what is stopping the FDA from delaying again in May? I thought your question was rhetorical, in that we both know that there is nothing stopping the FDA from delaying again, and again. I just call them F-Delay. It's maddening and I wish there were some recourse as Harry suggests there should be. Alas, not going to happen. |
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Post by sellhighdrinklow on Feb 24, 2022 11:41:20 GMT -5
Dr. Rothblatt speaking on today’s uthr conference call. “ our super convenient tyvaso dpi product remains well positioned for its may 2022 launch. The fda did just delay it’s approval decision from this month to may but that 3 month delay is not important compared to the products block buster revenue potential and patent life well into the 2030’s. Three month delay to start on a billion dollar revenue trajectory is no big deal.” This starts at 6:25 on the conference call 🙏 ! |
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Post by sportsrancho on Feb 24, 2022 11:47:10 GMT -5
I’m hearing Nate sent out emails to people anybody get one?
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Post by hopingandwilling on Feb 24, 2022 11:47:49 GMT -5
What I don’t understand—when the FDA delayed approval last fall MannKind stated this was related to an issue with a third-party testing facility and there was no issue with the actual drug.
With today’s press they state the issue is related to a pulmonary safety issue with Tyvaso DPI.
Big difference in my way of thinking.Which is it?
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Post by prcgorman2 on Feb 24, 2022 12:05:01 GMT -5
What I don’t understand—when the FDA delayed approval last fall MannKind stated this was related to an issue with a third-party testing facility and there was no issue with the actual drug. With today’s press they state the issue is related to a pulmonary safety issue with Tyvaso DPI. Big difference in my way of thinking.Which is it? Careful. They didn’t say there was a pulmonary safety issue. They said they were following up on a complicated citizen’s petition questioning the safety and received so much material in response from UTHR that they needed until May to respond. Claiming there is a concern and demonstrating a concern are not the same thing. |
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