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Post by lakon on Oct 18, 2021 6:09:58 GMT -5
I hope I'm wrong. It sure seems like a corrupt way to delay for another year, and who benefits? The "deciders" who knew it was coming... At least this time, MNKD seemed prepared for the worst case as if they knew too...
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Post by peppy on Oct 18, 2021 6:13:30 GMT -5
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Post by akemp3000 on Oct 18, 2021 6:21:19 GMT -5
Knowing the huge life changing benefit to PAH patients has been put on hold, this sounds political. Whatever the small issue with the 3rd party, it should have been resolved. Hopefully, this will be resolved much sooner than six months. Glad MNKD raised the funds they did. Looks like they had a plan B.
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Post by sportsrancho on Oct 18, 2021 6:22:56 GMT -5
If LQDA gets approved November 7 you have to factor in the revenue loss on our end.
They are way up pre-market.
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Post by anderson on Oct 18, 2021 6:33:24 GMT -5
Would it have been better to release this news Friday after market to let people digest this and chill out over the weekend. Seems like this will make maximum impact on the share price the way this was done.
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Post by cretin11 on Oct 18, 2021 6:38:49 GMT -5
At least Nate can start pounding his “Strong buy under 5” again. And reminding us “I always told you not to own more shares than you can sleep comfortably with” - sage advice to those who have never invested in a stock before. |
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Post by sportsrancho on Oct 18, 2021 6:47:30 GMT -5
At least Nate can start pounding his “Strong buy under 5” again. And reminding us “I always told you not to own more shares than you can sleep comfortably with” - sage advice to those who have never invested in a stock before. The moral of the story is you listen to the realists. Not someone who goes after people he mistakenly thinks are shorts…then warns there’s no guarantees and gets out of dodge. |
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Post by mango on Oct 18, 2021 6:48:46 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.
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Post by mango on Oct 18, 2021 6:49:42 GMT -5
If LQDA gets approved November 7 you have to factor in the revenue loss on our end. They are way up pre-market. FDA is prohibited from approving Liquidia due to the Hatch Waxman Act. They can only give a “tentative approval” at best and even then Liquidia will not be able to market and sell their product until after litigation is resolved or until after October 2022 next year, whichever occurs first. Court trial is scheduled for March 2022 and will likely drag on for a long time. MannKind will still get to market first. |
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Post by hellodolly on Oct 18, 2021 7:45:17 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.
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Post by sweedee79 on Oct 18, 2021 7:52:18 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!! |
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Post by peppy on Oct 18, 2021 7:54:55 GMT -5
Well, for those who thought the approval was "priced in" since last November at $2.00 and $5.43 was the area of resistance, you all should be buying "hand over fist" today knowing approval is definite AND it could come early. I know I will be looking for that area to pull the trigger on a 100% winning trade. There are so many twists and turns with this stock.. nothing is definite!! We know the label. No black box. The draft labeling for Tyvaso DPI, as revised by FDA, includes the same indications as Tyvaso® (treprostinil) Inhalation Solution for PAH and PH-ILD, to improve exercise ability, and does not contain any contraindications or a boxed warning. "We are very pleased with the FDA's feedback on the label, which will ultimately enable us to bring Tyvaso DPI to thousands of patients in need," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier." |
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Post by veritasfiliatemporis on Oct 18, 2021 8:02:47 GMT -5
You know, this is a moment where I make money, one news that basically saying.. there is a delay bla bla, but all others more important issues have been approved, ....and panic!! I hope I can buy some at 4$, if you pls stop to write logical statements ... Thanks, I will appreciate
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Post by sportsrancho on Oct 18, 2021 8:09:25 GMT -5
Have to let this play out and see how the market reacts, there are no catalysts with at this point to bring it back up, I’d say give it a couple weeks.
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Post by celo on Oct 18, 2021 8:21:33 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.
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