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Post by mnkdfann on May 23, 2022 10:37:49 GMT -5
It is entirely possible that MNKD applied for this date months ago with the hope that the NDA would be approved ahead of it. It is entirely possible that MNKD wanted to ring the bell the same day it announced the purchase of VGO last week, but the first available bell ringing opportunity was the week following (i.e. next week). Looks like I called it. At the very least, I was closer to real life events in my prediction than most of the hopium addicts were.  |
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Post by LongMNKD on May 23, 2022 10:57:04 GMT -5
Maybe a little off topic - If an announcement from the FDA is today, when can we expect something by? Would we have already heard something?
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Post by prcgorman2 on May 23, 2022 11:06:25 GMT -5
My experience has been if there is a company press release, typically that is set to 'go' (whatever that means) at 6am Eastern. That said, if the FDA gives UTHR the nod today, I assume they could arrange either an immediate release, or schedule one for after hours. Since we're now three-fourths of the way through May, I'm getting increasingly concerned what the FDA might do. The uncertainty with regard to the FDA is why I reduced my holdings of MNKD. I did add some back when the price was close to $3, but I've no plans to add more until after the FDA renders their decision.
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Post by sportsrancho on May 23, 2022 11:20:34 GMT -5
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Post by mymann on May 23, 2022 11:29:45 GMT -5
Nothing more than an advertisement for mnkd and free trip to NY for employees. Not what most of us expected.
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Post by akemp3000 on May 23, 2022 11:33:44 GMT -5
Mentioning V-Go shows Mike has a clear and definitive reason for the purchase even if we don't understand the logic and details. The "string of pearls" path is certainly better than the "veins of gold" that haven't yet transpired  |
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Post by sayhey24 on May 23, 2022 12:18:17 GMT -5
Mentioning V-Go shows Mike has a clear and definitive reason for the purchase even if we don't understand the logic and details. The "string of pearls" path is certainly better than the "veins of gold" that haven't yet transpired  I sure hope you and Mike are right and I am wrong. I don't see it. Kendall at least got the "inhaled insulin" mention in the T1 SoC until something happened and he left. It would have been nice if he had gotten the new ADA Class of "Monomer Insulin". Right now its sitting in the "Rapid Acting" class and needs to be moved. |
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Post by mnkdfann on May 23, 2022 13:27:12 GMT -5
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Post by sayhey24 on May 23, 2022 13:45:05 GMT -5
What an odd article. The FDA never announces the approval. They will notify UTHR. The announcement will come from UTHR but it sure seems its coming.
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Post by prcgorman2 on May 23, 2022 13:48:34 GMT -5
Yeah, odd is right. WHERE is the REAL announcement? Hopefully, there's a usable link [not Seeking Alpha self-publishing pseudo-journalism] somewhere.
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Post by mango on May 23, 2022 13:50:16 GMT -5
Looks like the hopium folks were right.
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Post by hellodolly on May 23, 2022 13:56:34 GMT -5
What an odd article. The FDA never announces the approval. They will notify UTHR. The announcement will come from UTHR but it sure seems its coming. In part from the FDA reply on the CP: Docket No. FDA-2021-P-0714 2 I. BACKGROUND A. Tyvaso DPI Today, FDA approved NDA 214324 for Tyvaso DPI submitted by United TherapeuticsCorporation (UTC) for the indications of the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI is a drug-device combination product that consists of single-use polyethylene cartridges containing dry powder formulation for pulmonary delivery with the Tyvaso DPI inhaler. There are 4 different strengths of the powder formulation (16 micrograms (mcg), 32 mcg, 48 mcg, and 64 mcg per cartridge).2 Tyvaso DPI therapy should begin with a single 16 mcg cartridge per treatment session, 4 times daily.3 Dosage should be increased by an additional 16 mcg per treatment session at approximately 1- to 2-week intervals.4 If adverse effects preclude titration, Tyvaso DPI should be continued at the highest tolerated dose.5 |
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Post by mango on May 23, 2022 14:04:56 GMT -5
It is entirely possible that MNKD wanted to ring the bell the same day it announced the purchase of VGO last week, but the first available bell ringing opportunity was the week following (i.e. next week). Looks like I called it. At the very least, I was closer to real life events in my prediction than most of the hopium addicts were. I think you spoke too soon. 😉 In part from the FDA reply on the CP: Docket No. FDA-2021-P-0714 2 I. BACKGROUND A. Tyvaso DPI Today, FDA approved NDA 214324 for Tyvaso DPI submitted by United Therapeutics Corporation (UTC) This is why Mike rang the bell. 😊 |
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Post by mnkdfann on May 23, 2022 14:08:09 GMT -5
Looks like I called it. At the very least, I was closer to real life events in my prediction than most of the hopium addicts were. I think you spoke too soon. 😉 In part from the FDA reply on the CP: Docket No. FDA-2021-P-0714 2 I. BACKGROUND A. Tyvaso DPI Today, FDA approved NDA 214324 for Tyvaso DPI submitted by United Therapeutics Corporation (UTC) This is why Mike rang the bell. 😊 In my defence, Mike didn’t think it was worth mentioning this morning. 😀 |
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Post by mango on May 23, 2022 14:17:39 GMT -5
I love how FDA states they approved Tyvaso DPI to Scott Lassman in his CP denial letter.
FDA clearly followed the science on this one folks. Could not ask for a better label.
Remember Gregonious and Findell Capital claiming Tyvaso DPI would have a warning and caused bronchospasm? Guess what, they're both FUDSTERS and liars and FDA confirmed it today.
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