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Post by ptass on Apr 28, 2022 9:27:32 GMT -5
During the last conference call I thought Mike said approval "by May" but he also mentioned a 90 day FDA review period. The year end call was held in late February but I believe the communication with the FDA was closer to the end of January. I know it sounds like splitting hairs but if the "by May" statement is correct, I feels like there could be another delay coming.
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Post by Clement on Apr 28, 2022 9:30:16 GMT -5
in May
during the month of May
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Post by sportsrancho on Apr 28, 2022 9:48:10 GMT -5
in May during the month of May đđ» |
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Post by peppy on Apr 28, 2022 10:31:49 GMT -5
May 4th is next Wednesday.
United Therapeutics Corporation (Nasdaq: UTHR) announced today that it will report its first quarter 2022 financial results before the market opens on Wednesday, May 4, 2022.
United Therapeutics will host a public webcast Wednesday, May 4, 2022, at 9:00 a.m. Eastern Time. The webcast will be accessible via United Therapeutics' website at ir.unither.com/events-and-presentations. A rebroadcast of the webcast will be available for one week and can be accessed at the same location.
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Post by prcgorman2 on Apr 28, 2022 10:43:51 GMT -5
The news is known, so what is it going to be? You wouldnât typically expect bad news on a Wednesday morning, would you? (But, this is MNKD...)
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Post by stockwhisperer on Apr 28, 2022 11:01:11 GMT -5
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Post by stockwhisperer on Apr 28, 2022 11:02:14 GMT -5
The news is known, so what is it going to be? You wouldnât typically expect bad news on a Wednesday morning, would you? (But, this is MNKD...) How do you know for sure the news is known? |
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Post by robbmo on Apr 28, 2022 11:02:27 GMT -5
The news is known, so what is it going to be? You wouldnât typically expect bad news on a Wednesday morning, would you? (But, this is MNKD...) I don't think any news is known, but if it was, I would think it is positive as the FDA would most likely wait until the last minute to issue a delay or CRL. If something is released early, it is usually an approval, I believe. |
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Post by stockwhisperer on Apr 28, 2022 11:05:44 GMT -5
During the last conference call I thought Mike said approval "by May" but he also mentioned a 90 day FDA review period. The year end call was held in late February but I believe the communication with the FDA was closer to the end of January. I know it sounds like splitting hairs but if the "by May" statement is correct, I feels like there could be another delay coming. I never heard MC say by May but he may have. UTHR definitely said, âby Mayâ in print - but only they know if they were thinking by the end of May or otherwise. www.businesswire.com/news/home/20220406005062/en/United-Th |
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Post by Clement on Apr 28, 2022 11:57:32 GMT -5
from UTHR's latest 10-K, Page 9: "On October 15, 2021, the FDA provided us a complete response letter (CRL) in which it declined to approve the Tyvaso DPI NDA. In its complete response, the FDA cited a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party analytical testing facility for treprostinil drug substance. The CRL noted, but did not cite as a deficiency, that the FDA had not yet completed its review of a Citizen Petition submitted to the FDA in July 2021 concerning the safety of an excipient in Tyvaso DPI. In December 2021, we resubmitted our NDA to the FDA, addressing the single deficiency cited in the CRL. In January 2022, the FDA accepted our resubmitted NDA for review, and designated our NDA as a class 1 resubmission with an expected two-month review period ending in February 2022. In February 2022, the FDA requested additional information concerning the pulmonary safety of Tyvaso DPI. We responded to the FDAâs request, and the FDA indicated that our response constitutes a major amendment to the Tyvaso DPI NDA, which extends the FDAâs anticipated deadline to review the pending NDA to May 2022."d18rn0p25nwr6d.cloudfront.net/CIK-0001082554/ec6421fd-7d6d-438b-a490-e519e772457b.html#UTHR-20211231_HTM_i3b8d4f904156410bae25b1f0a8e0a586_13 |
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Post by sportsrancho on Apr 28, 2022 12:03:52 GMT -5
from UTHR's latest 10-K, Page 9: "On October 15, 2021, the FDA provided us a complete response letter (CRL) in which it declined to approve the Tyvaso DPI NDA. In its complete response, the FDA cited a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party analytical testing facility for treprostinil drug substance. The CRL noted, but did not cite as a deficiency, that the FDA had not yet completed its review of a Citizen Petition submitted to the FDA in July 2021 concerning the safety of an excipient in Tyvaso DPI. In December 2021, we resubmitted our NDA to the FDA, addressing the single deficiency cited in the CRL. In January 2022, the FDA accepted our resubmitted NDA for review, and designated our NDA as a class 1 resubmission with an expected two-month review period ending in February 2022. In February 2022, the FDA requested additional information concerning the pulmonary safety of Tyvaso DPI. We responded to the FDAâs request, and the FDA indicated that our response constitutes a major amendment to the Tyvaso DPI NDA, which extends the FDAâs anticipated deadline to review the pending NDA to May 2022."d18rn0p25nwr6d.cloudfront.net/CIK-0001082554/ec6421fd-7d6d-438b-a490-e519e772457b.html#UTHR-20211231_HTM_i3b8d4f904156410bae25b1f0a8e0a586_13Funny how you tell people and nobody listensđ€Ł I heard sometime in May. Email |
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Post by prcgorman2 on Apr 28, 2022 12:48:11 GMT -5
The news is known, so what is it going to be? You wouldnât typically expect bad news on a Wednesday morning, would you? (But, this is MNKD...) I don't think any news is known, but if it was, I would think it is positive as the FDA would most likely wait until the last minute to issue a delay or CRL. If something is released early, it is usually an approval, I believe. You may be right. I was assuming that since UTHR and MNKD issued press releases earlier today saying that their earnings reports will be next Wednesday morning that they already either have the FDA decision, or will have it by then. If they already have the decision, it met the definition of âby Mayâ. If they donât already have the decision, but do know they will have it by then, it seems risky to have scheduled the earnings report for first thing in the morning. Perhaps similar logic with other investors is what is driving the volume and upward price movement. |
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Post by boca1girl on Apr 28, 2022 15:10:12 GMT -5
You guys are making my head spin with all your hand ringing and getting twisted up in your shorts. The anxiety level is pretty high and youâve already been disappointed twice. I doubt either company has already learned the decision because they probably have to disclose material news within 3 days.
We should plan on the end of May, and if we get a decision earlier than that, you can celebrate. I believe we have weekly options all month long. The option players should buy out in June to give themselves a little bit of breathing room. Any $5 option in May or June is a crap shoot anyway with the current weakness in the market. I wouldnât be surprised if MNKD did not make it back to $5 with a FDA approval.
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Post by sportsrancho on Apr 28, 2022 17:21:45 GMT -5
Right youâre betting on the market going up at the same time we get a positive announcement. Cuts your odds in half.
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Post by ptass on Apr 28, 2022 22:32:26 GMT -5
'in May' is likely what was either said or intended. Been sucker punched --hard-- to many effin times it's got me paranoid.
On another note: I believe Mike thinks and acts like an employee. Case in point: during last call's Q&A session an analyst asked (I ad lib) if they had any plans to deploy their excess cash into distresses companies. This was a stupid question and Mike answered appropriately (ie yeah, we've always have our eyes out for opportunities). This becomes a bullet point on a subsequent presentations. So this guy's editing PowerPoints thinking small and like I said, doing a job (not saying he isn't working hard). He just has no industry clout... At all.
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