|
|
Post by radgray68 on Feb 24, 2022 12:12:14 GMT -5
A small part of me wants to be stoic. I want to say "C'est la vie." We'll get 'em next time." But at this moment, my inner child just wants to cry.
Apparently, the world IS just as corrupt as I feared. May God help us all.
|
|
|
|
Post by stockwhisperer on Feb 24, 2022 12:14:35 GMT -5
Sounds like the FDA could use some process changes…. “Who’s on first”. Do they talk to each other. Why approve a priority review then let simple things In a citizens petition - that you would think were already known or addressed, further delay things. So, why was the priority review approved in the first place. Then, why send a letter saying that there is only 1 issue to resolve prior to an FDA decision. Next, after another wait, why say, a decision will be made in Feb. That citizens petition had been out there for months, finally receiving an interim response in early Jan. I suspected that was a big red flag. Are the people who receive the citizens petitions on a different planet than the FDA priority review decision making team. I have no idea. Seems there are games at every turn. Set the calendar to May.
|
|
|
|
Post by harryx1 on Feb 24, 2022 12:24:21 GMT -5
|
|
|
|
Post by mnkdfann on Feb 24, 2022 12:35:47 GMT -5
I’m hearing Nate sent out emails to people anybody get one? Saying what? Or what have you heard? |
|
|
|
Post by sportsrancho on Feb 24, 2022 12:38:29 GMT -5
I’m hearing Nate sent out emails to people anybody get one? Saying what? Or what have you heard? I heard but I didn’t see the email. “Very frustrated.” I guess. |
|
|
|
Post by sayhey24 on Feb 24, 2022 12:43:46 GMT -5
A small part of me wants to be stoic. I want to say "C'est la vie." We'll get 'em next time." But at this moment, my inner child just wants to cry. Apparently, the world IS just as corrupt as I feared. May God help us all. It seems Martine took the FDA news in stride saying they are ready for product launch in May. After being around MNKD all these years what else should we have expected but another FDA curveball. MNKD is just a snake bit company. I am not sure I fully under the statement in the PR "the FDA has considered this response to be a major amendment to the NDA". Was UTHR ready for the question and respond in such detail that the FDA needed time to review the response? I guess we get to hear Mike's side of the story at 5pm. What we do know is Technosphere has proven to be highly safe and beyond what anyone expected. |
|
|
|
Post by dh4mizzou on Feb 24, 2022 12:54:34 GMT -5
If I'm Martine and UTHR I'm trying to come up with a way to make LQDA "No More"
|
|
|
|
Post by peppy on Feb 24, 2022 13:03:57 GMT -5
I am going to get an FDA approved cigarette, and take some FDA approved Bismuth, an alkaline metal, Pepto Bismol and read what the FDA has decided. |
|
|
|
Post by mango on Feb 24, 2022 13:40:23 GMT -5
|
|
|
|
Post by epc1355 on Feb 24, 2022 13:44:58 GMT -5
Nate’s email was his usual take. In a nutshell: Surprised about the decision. FDA either corrupt or inept. Still believes in the company, and although frustrated, still believes Tyvaso DPI will be approved eventually, so not getting too worked up by the delay. Own/buy as much as you can and still comfortably sleep.
|
|
|
|
Post by radgray68 on Feb 24, 2022 13:49:10 GMT -5
Tonight, I'm getting sh__faced drunk.
A toast:
May every last one of the corrupt MF'ers at the FDA die of a long, miserable case of PAH. May they spend their last agonizing months on earth gasping for a cleansing breath that will never come. May they die with their faces stuck to a nebulizer saying to themselves " I did this to myself"
|
|
|
|
Post by mango on Feb 24, 2022 13:50:18 GMT -5
Listen to UTHR call today. Ask yourself, why is Martine so upbeat and calling Tyvaso DPI a blockbuster?
The answer is simple—Martine is 10 steps ahead of the losers at Liquidia and their wannabe attorney, Scott Lassman.
Martine submitted a Major Amendment to the NDA. All part of the plan. We knew this was coming.
Fear not MannKind and United Longs.
“Major Amendment – an amendment to an original application, efficacy supplement, manufacturing supplement or resubmission of any of these applications, including biosimilars, that extends the review clock.”
I believe we used the CP to our advantage and were well prepared ahead of time, months in advance, in case FDA pulled this chit. We will win.
|
|
|
|
Post by harryx1 on Feb 24, 2022 13:51:33 GMT -5
If for some reason (hopefully for the better) Martine did initiate the amendment then she better throw MNKD a bone in some shape or fashion (buy-in, new molecule, etc.) as she should have fully known how this was going to impact MNKD's share price. What would Martine add to the NDA??? |
|
|
|
Post by cretin11 on Feb 24, 2022 14:37:02 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? Agree there is a big difference. Appears the statement last fall wasn’t 100% accurate or complete. It is puzzling. |
|
|
|
Post by sweedee79 on Feb 24, 2022 14:43:44 GMT -5
A small part of me wants to be stoic. I want to say "C'est la vie." We'll get 'em next time." But at this moment, my inner child just wants to cry. Apparently, the world IS just as corrupt as I feared. May God help us all. My inner child is sobbing!!! So f#@+#king tired of this!!!! 😭 |
|
