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Post by Clement on Sept 16, 2021 16:10:30 GMT -5
As far as I know, the FDA said there will be a decision on Tyvaso DPI in October. Why are people on this board claiming there will be an Oct 15 decision?
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Post by parrerob on Sept 16, 2021 16:46:09 GMT -5
Take a look to a post from Harryx1, june 16, under ^UTHR Tyvaso Approval^ subject.....
Seems that date has been posted by biopharmcatalyst.com
Don't know if coming from fda or just an assumption by biopharm
Any how We all know that the date could be later or even before
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Post by Clement on Sept 16, 2021 17:01:28 GMT -5
Do you have this information actually from the FDA website?
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Post by sportsrancho on Sept 16, 2021 18:14:41 GMT -5
As far as I know, the FDA said there will be a decision on Tyvaso DPI in October. Why are people on this board claiming there will be an Oct 15 decision? I’ve seen it in print. I’m thinking Mike alluded to that date also but I’m not positive ..I’ll try to go find it somewhere. |
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Post by akemp3000 on Sept 16, 2021 19:27:07 GMT -5
I've followed the FDA calendar schedule Harry posted for many years tracking no less than 40 other biotech stocks with pending FDA decisions. When a date is posted, such as October 15 for the forthcoming UTHR decision, the odds are very high that the FDA will make a decision on that date or on rare occasion sooner. Early decisions, even six weeks prior to the posted date, are usually when the FDA decides to issue a CRL delay and require more information. This isn't likely here. I've yet to see the FDA not make a decision or respond by the posted date. That said, very little relating to MNKD has ever been considered normal  |
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Post by stockwhisperer on Sept 16, 2021 20:54:46 GMT -5
I saw Oct. 15th at www.biopharmcatalyst.com/calendars/pdufa-calendar. It is still shown that way, under catalysts. The calendar selection, says October. Some other site calendars show October, as well. While an FDA decision might apply to a specific date and often does, I am not sure if that same thesis applies to FDA Priority Review decisions. In in case, what I have read implies the decision is ‘BY’ a certain date or timeframe, which theoretically could be anytime between now and the end of October, depending on individual interpretation. |
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BIGWIG
Newbie
Posts: 15 
Sentiment: Long
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Post by BIGWIG on Sept 16, 2021 21:37:30 GMT -5
If approved in October, when is likely date that sales of the new formulation will begin?
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Post by sportsrancho on Sept 16, 2021 21:39:23 GMT -5
I saw Oct. 15th at www.biopharmcatalyst.com/calendars/pdufa-calendar. It is still shown that way, under catalysts. The calendar selection, says October. Some other site calendars show October, as well. While an FDA decision might apply to a specific date and often does, I am not sure if that same thesis applies to FDA Priority Review decisions. In in case, what I have read implies the decision is ‘BY’ a certain date or timeframe, which theoretically could be anytime between now and the end of October, depending on individual interpretation. I thought it was you that knew ..thank you! 15 AVDL MNKD UTHR |
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Post by parrerob on Sept 17, 2021 3:43:39 GMT -5
Under biopharmcatalyst.com calendar I noticed now that for each event/day there is also a comment on the right.
While some comments report the exact date setted by FDA, under Tyvaso DPI comment is written "PDUFA expected in October 2021".... so I think biopharma setted the date in the middle of the month, but in reality expectation should stay under the full month (could be October 1st, or October 31st)
"NDA filing acceptance announced June 16, 2021 under priority review. PDUFA expected in October 2021. Clinical data presented at European Respiratory Society displayed safety and tolerance with improvements in six-minute walk distance, device preference and satisfaction, and patient-reported outcomes September 7, 2021"
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Post by Clement on Sept 17, 2021 6:34:59 GMT -5
Under biopharmcatalyst.com calendar I noticed now that for each event/day there is also a comment on the right. While some comments report the exact date setted by FDA, under Tyvaso DPI comment is written "PDUFA expected in October 2021".... so I think biopharma setted the date in the middle of the month, but in reality expectation should stay under the full month (could be October 1st, or October 31st) "NDA filing acceptance announced June 16, 2021 under priority review. PDUFA expected in October 2021. Clinical data presented at European Respiratory Society displayed safety and tolerance with improvements in six-minute walk distance, device preference and satisfaction, and patient-reported outcomes September 7, 2021" Thanks, Parrerob. Now that makes sense. In the recent fireside chat (Sept. 13) by Mike C at HC Wainwright conference, I listened carefully and Mike only said 4 to 6 weeks (through end of October). |
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Post by casualinvestor on Sept 17, 2021 8:11:31 GMT -5
It would be a shame if they actually did post it on the 15th, since that's a Friday.
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Post by cretin11 on Sept 17, 2021 14:01:06 GMT -5
It would be a shame if they actually did post it on the 15th, since that's a Friday. True, but it would make for an interesting options expiry day… |
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Post by peppy on Sept 17, 2021 14:04:34 GMT -5
If approved in October, when is likely date that sales of the new formulation will begin? I think samples will be ordered immediately by UTHR to be distributed by their sales team. something about threads of gold. my memory is failing me. |
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Post by cedafuntennis on Sept 17, 2021 15:03:24 GMT -5
Gold veins I think it was
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Post by mnkdfann on Sept 17, 2021 15:05:53 GMT -5
Gold veins I think it was Veins have worn down to threads, is what I thought peppy was going for. Or I may be giving her sarcastic wit too much credit.  |
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