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Post by lazyb767 on Oct 18, 2021 8:22:43 GMT -5
Well that was $105M wasted unless this gets reversed quickly. The worst part is all the PAH patients having to wait to improve their lives. This "third party" has got to be feeling some heat. Will be interesting to see what the options are. |
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Post by lazyb767 on Oct 18, 2021 8:27:24 GMT -5
“We continue to build pre-launch inventory of Tyvaso DPI and look forward to supporting United Therapeutics’ efforts in securing approval of Tyvaso DPI in the coming months,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation ( MNKD ).  |
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Post by peppy on Oct 18, 2021 8:30:51 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. |
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Post by sayhey24 on Oct 18, 2021 8:37:01 GMT -5
The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind’s facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device. The CRL is on UT, not us. Mango - this CRL to me is a huge deal. According to the UTHR release "The complete response also notes, but does not cite as a deficiency, that the FDA has not yet completed its review of a Citizen's Petition submitted to FDA in July 2021 concerning the safety of an excipient in Tyvaso DPI" My concern was the Citizen's petition would be cited and the FDA would start asking for the FDKP safety studies. It seems that did not happened which is great news for MNKD. It seems the black box warning will not be required. Could the FDA still throw a curveball, I guess but in 6 years of afrezza use I am not sure the black box should be on afrezza either. While royalties may be delayed for a few months, Mike is in a great financial position. I would trade a delay in royalties for no black box and its future implications for other Technosphere products, maybe even a label update for Afrezza. At the same time MNKD is getting paid to make Tyvaso which should cover factory costs. |
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Post by awesomo on Oct 18, 2021 8:38:44 GMT -5
The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind’s facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device. The CRL is on UT, not us. Mango - this CRL to me is a huge deal. According to the UTHR release "The complete response also notes, but does not cite as a deficiency, that the FDA has not yet completed its review of a Citizen's Petition submitted to FDA in July 2021 concerning the safety of an excipient in Tyvaso DPI" My concern was the Citizen's petition would be cited and the FDA would start asking for the FDKP safety studies. It seems that did not happened which is great news for MNKD. It seems the black box warning will not be required. Could the FDA still throw a curveball, I guess but in 6 years of afrezza use I am not sure the black box should be on afrezza either. While royalties may be delayed for a few months, Mike is in a great financial position. I would trade a delay in royalties for no black box and its future implications for other Technosphere products, maybe even a label update for Afrezza. At the same time MNKD is getting paid to make Tyvaso which should cover factory costs. Dude, it says right there that "the FDA has not yet completed its review...". So given another 6-9 months, they can certainly review it. |
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Post by veritasfiliatemporis on Oct 18, 2021 8:40:30 GMT -5
1500 at 4.2 Peppy without your comments I was able to buy at 3.5 you own me 0.7 x 1500 1050$.. cash pls
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Post by hellodolly on Oct 18, 2021 8:40:31 GMT -5
Well, for those who thought the approval was "priced in" since last November at $2.00 and $5.43 was the area of resistance, you all should be buying "hand over fist" today knowing approval is definite AND it could come early. I know I will be looking for that area to pull the trigger on a 100% winning trade. There are so many twists and turns with this stock.. nothing is definite!! Yes, but not this time. This is UTHR taking the lead and everything else is fine, per the FDA with the exception of a third party who needs to tidy up a few things. Yes, this is definite. |
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Post by veritasfiliatemporis on Oct 18, 2021 8:42:38 GMT -5
1500 at 4.2 Peppy without your comments I was able to buy at 3.5 you own me 0.7 x 1500 1050$.. cash pls Peppy " I want my money back "   |
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Post by peppy on Oct 18, 2021 9:10:18 GMT -5
1500 at 4.2 Peppy without your comments I was able to buy at 3.5 you own me 0.7 x 1500 1050$.. cash pls 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? |
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Post by sayhey24 on Oct 18, 2021 9:15:19 GMT -5
Mango - this CRL to me is a huge deal. According to the UTHR release "The complete response also notes, but does not cite as a deficiency, that the FDA has not yet completed its review of a Citizen's Petition submitted to FDA in July 2021 concerning the safety of an excipient in Tyvaso DPI" My concern was the Citizen's petition would be cited and the FDA would start asking for the FDKP safety studies. It seems that did not happened which is great news for MNKD. It seems the black box warning will not be required. Could the FDA still throw a curveball, I guess but in 6 years of afrezza use I am not sure the black box should be on afrezza either. While royalties may be delayed for a few months, Mike is in a great financial position. I would trade a delay in royalties for no black box and its future implications for other Technosphere products, maybe even a label update for Afrezza. At the same time MNKD is getting paid to make Tyvaso which should cover factory costs. Dude, it says right there that "the FDA has not yet completed its review...". So given another 6-9 months, they can certainly review it. 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. |
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Post by cjm18 on Oct 18, 2021 9:16:50 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. But they told me daily short interest didn’t matter. |
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Post by nemzter on Oct 18, 2021 9:17:18 GMT -5
Well that was $105M wasted unless this gets reversed quickly. The worst part is all the PAH patients having to wait to improve their lives. This "third party" has got to be feeling some heat. Will be interesting to see what the options are. Hopefully it's not Hakan or Pfeffer working for this 3rd party, but that wouldn't surprise me either. GLTA |
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Post by sweedee79 on Oct 18, 2021 9:20:41 GMT -5
There are so many twists and turns with this stock.. nothing is definite!! Yes, but not this time. This is UTHR taking the lead and everything else is fine, per the FDA with the exception of a third party who needs to tidy up a few things. Yes, this is definite. The citizen petition hasn't been reviewed yet.... I will consider it definite when we have an actual approval.. It's been a long week.. sure wasn't expecting this!!! |
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Post by BD on Oct 18, 2021 9:21:22 GMT -5
The band is just fantastic, that is really what I think. By the way, which one's Pink? |
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Post by awesomo on Oct 18, 2021 9:26:26 GMT -5
Dude, it says right there that "the FDA has not yet completed its review...". So given another 6-9 months, they can certainly review it. 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. |
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