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Post by Clement on Oct 16, 2021 7:06:45 GMT -5
Thanks for the link! The link shows a list of October approvals that was produced on October 16. However, when you look at the entries of approvals so far in October, you only see October 1 through October 14. October 15 has not yet been entered into this list on this link. I conclude that a pre-market announcement on Monday is still possible. (However, I think it could be any day from now to October 31.) |
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Post by lakon on Oct 16, 2021 9:31:17 GMT -5
I'm pretty sure the FDA's and Company's lawyers see to it that the information gets released about the same time due to potential economic/legal advantage/disadvantage of a surprise release by either party...
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Post by veritasfiliatemporis on Oct 16, 2021 11:42:30 GMT -5
And They didn't work on Columbus day...   |
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Post by veritasfiliatemporis on Oct 16, 2021 11:49:20 GMT -5
and of course "Indigenous Peoples’ Day" ...
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Post by mannmade on Oct 16, 2021 12:08:39 GMT -5
I have to admit that the MNKD price action going into what is supposed to be a near term PDUFA date, in October, sure seems strange as I think given the P3 results and the fact that both the API and TS are already approved in other uses. Is it Halloween, is it the shorts? Approval priced in? Is it something to do with LQDA? something else, such as a restrictiion on use with the label? Pictures of the Trep T inhaler going up in the lobby of UTHR, an expedited payment made by a very smart CEO we all respect... all bode well for my belief that Trep T will be approved. I am really not sure what it could be that keeps the pps suppressed... So while imho I expect Trep T to be approved, as a very long long with MNKD I feel like the tortured step child as I/we yet again await an outcome that is not conforming to the norm of expected progression in its last few days... GLTAL's!!!  |
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Post by akemp3000 on Oct 16, 2021 12:37:29 GMT -5
Agreed that the mostly stable price action going into this PDUFA date has not been normal though it's technically UTHR that applied for the decision. While we all know the decision affects MNKD greatly, that's not necessarily the case with many investors. If a good or bad decision was made on Friday, we'd have seen a significant late day price swing from insider knowledge. IMO we should hear something Monday. There are 105 million reasons the decision won't be delayed. Even though UTHR purchased the expedited review from another biotech company, the FDA can't afford for the expedited review process to be de-valued. A big pre-market move Monday morning would not be surprising.
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Post by lazyb767 on Oct 16, 2021 12:47:19 GMT -5
Agreed that the mostly stable price action going into this PDUFA date has not been normal though it's technically UTHR that applied for the decision. While we all know the decision affects MNKD greatly, that's not necessarily the case with many investors. If a good or bad decision was made on Friday, we'd have seen a significant late day price swing from insider knowledge. IMO we should hear something Monday. There are 105 million reasons the decision won't be delayed. Even though UTHR purchased the expedited review from another biotech company, the FDA can't afford for the expedited review process to be de-valued. A big pre-market move Monday morning would not be surprising. I have to get up early again.  |
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Post by mannmade on Oct 16, 2021 12:48:38 GMT -5
Agreed that the mostly stable price action going into this PDUFA date has not been normal though it's technically UTHR that applied for the decision. While we all know the decision affects MNKD greatly, that's not necessarily the case with many investors. If a good or bad decision was made on Friday, we'd have seen a significant late day price swing from insider knowledge. IMO we should hear something Monday. There are 105 million reasons the decision won't be delayed. Even though UTHR purchased the expedited review from another biotech company, the FDA can't afford for the expedited review process to be de-valued. A big pre-market move Monday morning would not be surprising. I have to get up early again. Yep! |
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Post by porkini on Oct 16, 2021 13:37:35 GMT -5
I was digging around the FDA site from the link above and came upon another page that would indicate they are (or always have been) on a 7-day and 14-day "publication schedule" of approvals. Should we already have known about this? Link: www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.pageSo, my question is, now knowing this page exists, did we collectively get our hopes up too high when we heard October 15 and thought we would know something concrete by that date? Approval may still be imminent or have occurred without notification and we will have to wait for them to update the next 7-day or 14-day cycle for us to know. |
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Post by mytakeonit on Oct 16, 2021 15:19:27 GMT -5
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Post by Chris-C on Oct 16, 2021 15:39:29 GMT -5
I think this thread is misnamed and as such, misleading. It has NOT been established that there is a delay in FDA approval. Neither company identified October 15 as a specific date for approval; (nor did the FDA); the companies only stated that the decision was expected in October, 2021. Thus, by any measure, it is not accurate to speculate on a delay until November 1.
With respect to the price action, I tend to agree that the share price gain of the past two weeks reflects a pricing in of anticipated approval. The weird gyrations of up and down finishes reflect the volatility of this stock. Any long has come to expect that Mannkinds price action is going to be unpredictable and inexplicable.
As far as Mannkind is concerned, the approval when it occurs will have benefits through production and royalty revenue as Tyvaso DPI is prescribed; and that won't begin until Q4, and will slowly ramp up and (we hope) positively affect MNKD's revenue/expense picture, (again, we hope) leading to positive cash flow by late 2022.
There are good things ahead for MNKD, but until they result in positive cash flow and solid fundamentals, significant street interest will be slow to come, IMHO.
So, would it be nice for UTHR to get an affirmative decision on Monday? Absolutely! But the wringing of hands on the board and in this thread is a side effect of too much hopium laced with too few facts.
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Post by buyitonsale on Oct 16, 2021 21:01:14 GMT -5
October 15th or any other date in October has never been mentioned by FDA or UTHR or MNKD. The only official information from UTHR IR is below. mnkd.proboards.com/post/224988 |
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Post by buyitonsale on Oct 16, 2021 21:48:32 GMT -5
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Post by buyitonsale on Oct 16, 2021 22:17:16 GMT -5
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Post by buyitonsale on Oct 16, 2021 22:19:28 GMT -5
That's all I got, plus 3 buy orders under 5 Looking forward to next week! |
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