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Post by veritasfiliatemporis on Oct 18, 2021 9:33:41 GMT -5
Peppy " I want my money back "   We all want our money back. Have you seen a chart? Also, you seem to be talking to your self. Are you on medication? yepp, Tyvaso how you know...30 Nov 1979 Margaret Thatcher...  |
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Post by peppy on Oct 18, 2021 9:34:18 GMT -5
The band is just fantastic, that is really what I think. By the way, which one's Pink? MNKD, yes the market has picked up, and MKND is down. If the band you are in starts playing a different tune....  |
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Post by sluggobear on Oct 18, 2021 9:38:06 GMT -5
Agreed, could there be a curveball, sure. However, at this point a safety request should have been cited and it was not. Now was the time. In the Tyvaso trials I am not aware of any Acute bronchospasm. Was there? If not its pretty hard to come back and ask without basis unless the 3rd party testing center actually did have these events and did not report them. They explicitly said that the review has not been completed. If they had said that they reviewed it and do not see an issue, that would be a different story. This is not positive verbiage leaving the door open like that. The FDA is very skeptical of Citizens Petitions because they have often been abused to hamstring competitors and slow down their approval process. FDA rarely, if ever, delays NDA approval based on a CP. www.centerforbiosimilars.com/view/fda-releases-final-guidance-to-determine-if-citizen-petitions-are-abusive |
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FDA delay
Oct 18, 2021 9:44:58 GMT -5
via mobile
Post by straightly on Oct 18, 2021 9:44:58 GMT -5
Looks like UTHR is down very little pre-market because they can continue to sell Tyvaso. Interesting, as it has been pointed out it was at their third party quality control sub. Mannkind however, would of liked the revenue stream. Continuing to sell, deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance. Not sure it makes sense. It could be something totally unrelated. True story: Alamo rental car. The credit card I have on me does not have its number on it. An employee refused to take it. No surprise there, some people enjoy being difficult. The manager would not take it either. After that employee’s shift was over 20 minutes later, the manager accepted my credit card. That did not make sense until I heard about the “severe” labor shortage. All this was done in the name of protecting consumers interests against whatever came into mind. Consumers/Patients are presumably the victims. |
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FDA delay
Oct 18, 2021 9:45:51 GMT -5
via mobile
Post by ptass on Oct 18, 2021 9:45:51 GMT -5
Agreed, could there be a curveball, sure. However, at this point a safety request should have been cited and it was not. Now was the time. In the Tyvaso trials I am not aware of any Acute bronchospasm. Was there? If not its pretty hard to come back and ask without basis unless the 3rd party testing center actually did have these events and did not report them. They explicitly said that the review has not been completed. If they had said that they reviewed it and do not see an issue, that would be a different story. This is not positive verbiage leaving the door open like that. Yeah it seems like the FDA needed more time and the 3rd party lab issues enabled them to get it. I do believe everything will ultimately be approved, but when is the question: end of year, end of 1st quarter? |
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Post by boca1girl on Oct 18, 2021 9:48:49 GMT -5
Didn’t Martin S’s CP have a negative affect on Afrezza’s approval? |
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Post by peppy on Oct 18, 2021 9:52:01 GMT -5
The band is just fantastic, that is really what I think. By the way, which one's Pink? So I'll talk turkey. A decision disappointment yes. Chart wise,  And to defend my self.... nice trades on BITCOIN and TESLA.... However it is difficult to be correct 100% of the time isn't it?  Additionally the reason, I replied ."no".  It is difficult to be correct 100% of the time. Peppy can be wrong. |
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Post by mannmade on Oct 18, 2021 10:08:30 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!!!  So this is a first... no not the CRL for Mannkind, but the fact that I am quoting myself. I am quoting myself to give recognition to Sports who has been telling me for the last SIX weeks that something was wrong with the way MNKD was trading. I would say to her what could go wrong??? The two main ingredients have already been approved by the FDA for other uses, we all saw the picture of the Trep T inhaler going up in UTHR's office, UTHR paid an extra $105m to expedite the review, Mnkd passed the factory inspection... So what could it be? And yet Sports stuck to her opinion that it was not trading right... And so I wrote the above post to relieve my own doubts about the upcoming PDUFA date. Who knew it would be a 3rd party testing site that would give cause to generate the CRL? Apparently both Nate, as he constantly reminded us the past few weeks, and the Shorts knew... The Shorts always seem to know... Some will likely see this as another buying opportunity and so I wish you all much luck... And as a long time long, I guess another NINE months is not so long to wait... Oh and by the way, Liane perhaps this thread should be entitled "FDA Decision Delayed" GLTAL's |
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Post by biffn on Oct 18, 2021 10:21:46 GMT -5
This has all the signs of a Martin S move. Seen it before here and other places.
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Post by cretin11 on Oct 18, 2021 10:23:02 GMT -5
The band is just fantastic, that is really what I think. By the way, which one's Pink? It’s a hell of a start, it could be made into a monster, if we all pull together as a team. |
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Post by peppy on Oct 18, 2021 10:27:42 GMT -5
Cretin isn't just an island
[C18: from French crétin, from Swiss French crestin, from Latin Chrīstiānus Christian, alluding to the humanity of such people, despite their handicaps]
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Post by sluggobear on Oct 18, 2021 10:29:55 GMT -5
They explicitly said that the review has not been completed. If they had said that they reviewed it and do not see an issue, that would be a different story. This is not positive verbiage leaving the door open like that. Yeah it seems like the FDA needed more time and the 3rd party lab issues enabled them to get it. I do believe everything will ultimately be approved, but when is the question: end of year, end of 1st quarter? An issue with a "3rd party analytical lab" could be something pretty basic like poor or deficient quality control and documentation. The FDA requires elaborate GMP & GLP procedures for manufacturing and analysis of active ingredients e.g. treprostinil. If UTHR uses a lab in India or other country, for instance, there may not be sophisticated or sufficient analytical GLP techniques and CAPA documentation for QC of the treprostinil DPI made by Mannkind. Just guessing because I assume this is same lab that analyzes their treprostinil and the only difference is the dry powder version. I also assume this should be an issue that is resolved in weeks by UTHR. But the time allotted for company response, and then revisiting & re-review by FDA pushes that out 6+ months. Hard to believe that UTHR wasn't on top of this. But we don't know much from the PR; they hold this stuff close to the vest. BTW I seriously doubt FDA just makes stuff up like this to cover for internal delay. |
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Post by boca1girl on Oct 18, 2021 10:30:12 GMT -5
This has all the signs of a Martin S move. Seen it before here and other places. History repeating itself. He must have connections/dirt on decision makers at the FDA. 😂 |
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Post by sayhey24 on Oct 18, 2021 12:18:24 GMT -5
This has all the signs of a Martin S move. Seen it before here and other places. History repeating itself. He must have connections/dirt on decision makers at the FDA. 😂 I thought about Martin on Friday, thinking could he make a return? The implications are huge if in fact the FDA give the green light for a clean label. If this is true "The draft labeling for Tyvaso DPI, as revised by FDA, includes the same indications as Tyvaso® (treprostinil) Inhalation Solution for PAH and PH-ILD, to improve exercise ability, and does not contain any contraindications or a boxed warning." the future of Technosphere and MNKD could be very bright. |
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Post by BD on Oct 18, 2021 12:38:10 GMT -5
The band is just fantastic, that is really what I think. By the way, which one's Pink? It’s a hell of a start, it could be made into a monster, if we all pull together as a team. Thanks, I got my lines mixed up LOL |
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