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Post by mango on Jun 9, 2021 8:23:22 GMT -5
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Post by anderson on Jun 9, 2021 10:11:19 GMT -5
The FDA has two months from the date of submission to accept the NDA. So the FDA has until June 19 or so to accept the NDA.
The 6-months for an approval decision is marked from the date of acceptance. That is why the anticipated approval has been projected for December. If the FDA accepts the NDA much earlier, say, sometime in May, then approval would be expected in November. But don't count on that happening. Expect the FDA to accept the NDA close to June 19 and approval about the same time in December. That's just the way it is.
And, yes, without other news the stock price will likely languish until we get closer to June 19, and then ditto for the time between acceptance and approval.
Well we are getting closer to that June 18th date, its a Friday. Note the 19th stated above is 61 days, those pesky 31 day months. P.S. isn't the 18th also quad witching date as well....could be interesting |
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Post by porkini on Jun 9, 2021 15:39:22 GMT -5
The FDA has two months from the date of submission to accept the NDA. So the FDA has until June 19 or so to accept the NDA.
The 6-months for an approval decision is marked from the date of acceptance. That is why the anticipated approval has been projected for December. If the FDA accepts the NDA much earlier, say, sometime in May, then approval would be expected in November. But don't count on that happening. Expect the FDA to accept the NDA close to June 19 and approval about the same time in December. That's just the way it is.
And, yes, without other news the stock price will likely languish until we get closer to June 19, and then ditto for the time between acceptance and approval.
Well we are getting closer to that June 18th date, its a Friday. Note the 19th stated above is 61 days, those pesky 31 day months. P.S. isn't the 18th also quad witching date as well....could be interesting Like "June"... right? www.fox5ny.com/news/rep-marjorie-taylor-green-wants-covid-19-answers-from-biden-by-june-31-2021  Note: This is coincidental and recent news in the past week, this is not meant to be political. |
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Post by peppy on Jun 9, 2021 15:54:17 GMT -5
funny, June has 30 days the joke. It is too stupid for the job. |
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Post by porkini on Jun 9, 2021 20:26:26 GMT -5
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Post by veritasfiliatemporis on Jun 16, 2021 5:14:01 GMT -5
Looks like UTHR has received NDA approval from FDA.... but you are still sleeping... I presume... David...
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Post by neil36 on Jun 16, 2021 5:22:17 GMT -5
October!
“which is expected to be complete in October 2021. The FDA has also indicated that they have not identified any potential review issues at this time.”
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Post by neil36 on Jun 16, 2021 5:26:14 GMT -5
“It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere® technology,” said Joe Kocinsky, MS, MBA, Chief Technology Officer of MannKind Corporation. “Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”
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Post by mango on Jun 16, 2021 5:43:09 GMT -5
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Post by akemp3000 on Jun 16, 2021 5:52:00 GMT -5
Love to see the excellent results of the BREEZE study included in the UTHR announcement. This success should eventually carry over to the acceptance and use of Afrezza. Too bad a comparable test wasn't submitted/allowed/accepted in the initial Afrezza application as everyone, including the FDA, should now recognize the results would have shown clear superiority. Al Mann knew this so it's possible the big three and the FDA also knew this which led to the FDA's poor and inadequate testing protocol requirements at the time which only showed non-inferiority. 20/20 hindsight isn't that useful but TS is now sure looking good moving forward.
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Post by sayhey24 on Jun 16, 2021 5:55:06 GMT -5
What got my attention - Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use. |
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Post by mango on Jun 16, 2021 5:59:50 GMT -5
What got my attention - Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use. I agree, that’s very exciting! Congrats everybody! 🥳 |
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Post by golfeveryday on Jun 16, 2021 6:04:30 GMT -5
What got my attention - Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use. I agree, that’s very exciting! Congrats everybody! 🥳 I am curious to see what the FDA does for the Afrezza black box warning and pulmonary function test requirement when they approve Tyvaso for a lung indication. |
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Post by cretin11 on Jun 16, 2021 6:37:04 GMT -5
I agree, that’s very exciting! Congrats everybody! 🥳 I am curious to see what the FDA does for the Afrezza black box warning and pulmonary function test requirement when they approve Tyvaso for a lung indication. Is FDA reviewing the Afrezza black box warning and PFT requirement? Would be great to get rid of those, but I don’t recall any news along those lines. |
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Post by mango on Jun 16, 2021 7:32:40 GMT -5
I am curious to see what the FDA does for the Afrezza black box warning and pulmonary function test requirement when they approve Tyvaso for a lung indication. Is FDA reviewing the Afrezza black box warning and PFT requirement? Would be great to get rid of those, but I don’t recall any news along those lines. MC indicated recently they were working with FDA on making the spirometry optional instead of required. Afrezza BBW has nothing to do with Tyvaso and likely will not be affected by it. We all know the BBW is completely unwarranted and not a cause of concern.      |
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