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Post by dh4mizzou on May 23, 2022 14:20:14 GMT -5
Sooooooo.. Does this imply that the Black Box Warning can be removed for Afrezza soon? I mean it's the same FDKP molecule, right?
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Post by kc on May 23, 2022 14:37:05 GMT -5
I have to say that Mike’s chosen words on his Twitter release were perfect. It’s about time we get some really good news. Today is a new beginning for many of us who have been hanging around since 2014.
We will see SHORTLY.
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Post by kc on May 23, 2022 14:38:41 GMT -5
Did anyone watch CNBC coverage of the opening bell? I wonder what they said about MNKD. Very strange the Jim Cramer (crapper) took the day off today. there is no mad money tonight. Seems to be perfect timing. |
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Post by kc on May 23, 2022 14:40:22 GMT -5
Very strange timing. You just have to wonder if they had a heads up several weeks ago. nevertheless it’s a proud day for many of us who have been around a long time. Mike did give credit to UTHR for helping to stabilize the company. Some here stated that UTHR’s lifeline with T-DPI wasn’t crucial to MNKD’s survival. Those who stated that probably know better now. It was a good move to mention UTHR and give them credit, we want people to associate us with UTHR as much as possible. Even though the approval didn’t happen in time for the bell ceremony, it’s still good exposure, as evidenced by this morning’s volume. And hopefully that just means more people are paying attention to MNKD when we do get the approval in a few days. |
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Post by kc on May 23, 2022 14:45:18 GMT -5
No blackbox warning. That’s very interesting. Perhaps Mannkind will be able to seek removal of the one for Afrezza 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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Post by cretin11 on May 23, 2022 16:38:41 GMT -5
Very strange timing. You just have to wonder if they had a heads up several weeks ago. nevertheless it’s a proud day for many of us who have been around a long time. Those who stated that probably know better now. It was a good move to mention UTHR and to give them credit, we want people to associate us with UTHR as much as possible. Even though the approval didn’t happen in time for the bell ceremony, it’s still good exposure, as evidenced by this morning’s volume. And hopefully that just means more people are paying attention to MNKD when we do get the approval in a few days. Indeed. I said a few days, shoulda said a few hours!  |
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Post by prcgorman2 on May 23, 2022 17:41:49 GMT -5
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. 😀 Don't be defensive, Mike wasn't in a position to mention it this morning, or he would have.
The news release and timing were definitely screwy. Not sure who goofed up what, but there was some fumbling is my opinion. (Don't want to point the finger at UTHR but that is who should have had their finger on the <send> button, not Mike.) |
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Post by kc on May 23, 2022 18:15:37 GMT -5
It will be very interesting to see what Tyvaso dpi sells for. The bong style application sells for a lot of money.
I would assume based on the price point of the traditional this will be quite a bit more economical and perhaps get into the hands of more patients which would mean a great royalty for mankind.
Doing a basic Internet search the current Tyvaso sells for over $25,000 per month retail value. It looks like a lot of Medicare patients get the product so I’m sure Medicare does not pay that kind of money.
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