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Post by hopingandwilling on Oct 15, 2021 17:11:27 GMT -5
Many expected a FDA response today for the Tre-t PDUFA. Avadel Pharma (AVDL)was also on the FDA schedule for today. Avadel received a notice from the FDA that they hadn’t finished their review and therefore delay they decision until a later date. The FDA gave no firm date as for when this would happen. The FDA didn’t request any more data or clarification issues.
If this is the same issue for UTRH—no reason too panic. At this time! I just wonder why the FDA didn’t inform them—like they did with Avadel.
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Post by MnkdWASmyRtrmntPlan on Oct 15, 2021 17:48:55 GMT -5
UTHR probably finished their review. There is some other reason why we haven't heard UTHR's status yet. Hopefully, we will hear next week.
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Post by derekewhitlock on Oct 15, 2021 18:03:35 GMT -5
If UTHR had received the same delay notification or a denial then I have to believe UTHR would have announced that at close of business today as is customary with bad news; thus, I feel confident that UTHR was noticed of approval today and plan on announcing at presentation early next week. Makes sense… right?
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FDA delay
Oct 15, 2021 18:10:48 GMT -5
via mobile
Post by neil36 on Oct 15, 2021 18:10:48 GMT -5
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Post by hopingandwilling on Oct 15, 2021 18:19:08 GMT -5
It appears that the FDA might not be able to decide until at least next month if the same criteria is applied as for Avadel. Avadel has filed a Form 8 concerning their delay--wonder why UTHR hasn't done the same--if they got the FDA notice!
"Avadel Pharmaceuticals announced today that the FDA notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible. In February 2021, the FDA accepted Avadel's NDA for FT218 and assigned a target action date of October 15, 2021. The NDA submission is supported by positive data from the pivotal Phase 3 REST-ON study, which was completed under a Special Protocol Assessment agreement with the FDA.
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Post by boca1girl on Oct 15, 2021 19:27:35 GMT -5
FDA delay  “Many expected an FDA response today”… Neither UTHR or MNKD published an Oct 15 decision date. Both communicated “October” only, without a date. How do we know that a decision has not been made and communicated to UTHR? Don’t they have 3 days to disclose that information? Isn’t the review of a NDA different than what Tre-T is going through being a combination of previously approved FDA drug and delivery mechanism? Did Avadel have a fast track voucher for review like UTHR has? It’s a stretch to conclude that both approvals will be delayed. I think many on this board are overly “emotional” or paranoid. The approval will come in the near future. It’s just a matter of days. (Too bad RLS’s CBD/panic attack drug isn’t available yet.) 😎 |
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Post by cjm18 on Oct 15, 2021 19:35:29 GMT -5
FDA delay “Many expected an FDA response today”… Neither UTHR or MNKD published an Oct 15 decision date. Both communicated “October” only, without a date. How do we know that a decision has not been made and communicated to UTHR? Don’t they have 3 days to disclose that information? Isn’t the review of a NDA different than what Tre-T is going through being a combination of previously approved FDA drug and delivery mechanism? Did Avadel have a fast track voucher for review like UTHR has? It’s a stretch to conclude that both approvals will be delayed. I think many on this board are overly “emotional” or paranoid. The approval will come in the near future. It’s just a matter of days. (Too bad RLS’s CBD/panic attack drug isn’t available yet.) 😎 Agree. Agree. But why is short interest up the last 2 days. Who would short heading into approval. They must already know bad news is coming. Got me. I’m paranoid. |
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Post by prcgorman2 on Oct 15, 2021 19:44:14 GMT -5
You gotta be kidding. Why would they short? Well, what if they didn’t borrow the shares? What if they had no intention of covering? Don’t get me started. I don’t see a landslide sell-off in motion so just more noise is my opinion.
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Post by sweedee79 on Oct 15, 2021 19:45:17 GMT -5
Do we even know for sure that today was the PDUFA date?
Some people seem pretty sure it is for whatever reason... It could be Monday... That would still be within the 6 month fast track.
I think many of us including me are nervous because we've waited so long .. and we've been burned before... yeah I could use some of that cbd from RLS... Haha
And we have that citizen petition and lqda trying to stir up trouble..
Also it's been strangely quiet for a while.. considering we are waiting for a PDUFA..
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Post by peppy on Oct 15, 2021 19:53:43 GMT -5
FDA delay “Many expected an FDA response today”… Neither UTHR or MNKD published an Oct 15 decision date. Both communicated “October” only, without a date. How do we know that a decision has not been made and communicated to UTHR? Don’t they have 3 days to disclose that information? Isn’t the review of a NDA different than what Tre-T is going through being a combination of previously approved FDA drug and delivery mechanism? Did Avadel have a fast track voucher for review like UTHR has? It’s a stretch to conclude that both approvals will be delayed. I think many on this board are overly “emotional” or paranoid. The approval will come in the near future. It’s just a matter of days. (Too bad RLS’s CBD/panic attack drug isn’t available yet.) 😎 Agree. Agree. But why is short interest up the last 2 days. Who would short heading into approval. They must already know bad news is coming. Got me. I’m paranoid. Quote, "a combination of previously approved FDA drug and delivery mechanism? " Good point, two in one. United Therapeutics Converts to a Public Benefit Corporation October 1, 2021 These people can't get enough oxygen from their lungs to the heart, they can barely walk. They are always on the verge of death. In subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerance with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes FDA action on New Drug Application for Tyvaso DPI expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Sept. 7, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) The BREEZE study The BREEZE study enrolled 51 subjects on a stable regimen of Tyvaso who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Top line data showing the BREEZE study met its primary objective were released in January 2021. Secondary objectives of the study included changes in six-minute walk distance (6MWD), device preference and satisfaction as evaluated through the Preference Questionnaire for Inhaled Treprostinil Devices (PQ-ITD), and patient reported PAH symptoms and impact (PAH-SYMPACT®). Primary safety and tolerability objective. Transition from Tyvaso to Tyvaso DPI demonstrated safety and tolerance. Forty-nine out of 51 patients (96%) completed the three-week treatment phase, while two subjects discontinued due to treatment-related adverse events during the treatment phase. There were no study drug-related serious adverse events. Most adverse events experienced during the study were mild to moderate in severity and occurred at severities and frequencies consistent with those seen in other inhaled treprostinil studies in patients with PAH. Please see Important Safety Information about Tyvaso at the end of this press release. Secondary objectives. Three weeks after switching from Tyvaso to Tyvaso DPI, patients in the BREEZE study demonstrated: Significant improvements in 6MWD compared to baseline. Improvements of 11.5 meters (p=0.0217) in 6MWD compared to baseline were observed through the three-week treatment phase. Significant improvements in overall satisfaction with the Tyvaso DPI inhaler. Using the PQ-ITD, significant improvements (p<0.0001) were observed in overall satisfaction with the Tyvaso DPI inhaler. Significant improvements in PAH Impact. The SYMPACT questionnaire includes domains on physical impacts, cognitive/emotional impacts, cardiopulmonary symptoms, and cardiovascular symptoms. Significant improvements in PAH impacts were observed in physical impacts (p=0.0438) and cognitive/emotional impacts (p=0.0048) at week three. |
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Post by sportsrancho on Oct 15, 2021 20:16:18 GMT -5
Seems Mannkind has spent an enormous amount of money over the last months hiring people. A delay of over a month would be a setback for sure.
But I think if it had gotten delayed they would’ve announced it like the other company did. So fingers crossed🙏🏻
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Post by wsulylecoug on Oct 15, 2021 20:58:26 GMT -5
If Martine had information to share, she would have done so. If there was ever a pharma CEO to be a trustworthy straight shooter, she’s it. The trial is good, the data is good, patients will love it. Have a beer, glass of wine, sip some scotch and enjoy the weekend. Cheers!!
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Post by buyitonsale on Oct 15, 2021 21:06:23 GMT -5
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Post by hellodolly on Oct 16, 2021 7:00:15 GMT -5
I was just going to post the link. There have been no new drug approvals by the FDA for calendar date 10/15/2021. I'm not sure when the Friday "New Drug Approval" list goes up? Sunday - midnight or Monday 8am? I've been monitoring it for a few days, subscribed to UTHR emails and with no information available, we can't assume anything until at a minimum, the list is posted. IMHO, once it is posted and IF it is not on the list, we can assume three things. 1) We've miscalculated the date, 2) There is a delay and the FDA wants more data/information, or 3) There is a bigger issue. I recall someone posting UTHR likes to publish their PRs after the market opens. This could be what they plan on doing but if so, the FDA 10/15/2021 list of approvals should be up. If we don't get an email or "yes-no-delayed" PR, we've miscalculated the date. |
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FDA delay
Oct 16, 2021 7:00:27 GMT -5
via mobile
Post by dh4mizzou on Oct 16, 2021 7:00:27 GMT -5
Curious. IF the FDA was delayed in responding and outside the window for the expedited review does UTHR get their money back?
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