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Post by peppy on Feb 24, 2022 19:14:29 GMT -5
Mike was speaking rather quickly today, but i think he said they had not been expecting today's FDA news and he was sorry about it, or words to that effect. I guess we'll see the transcript soon enough. But if Martine knew it was coming (and i'm not necessarily agreeing with mango that she did), wouldn't she have told Mike? Spew it out.  |
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Post by mango on Feb 24, 2022 19:19:28 GMT -5
Mike said in the call (paraphrasing) that they put together such a comprehensive package that it became a major amendment to the NDA and he’s not worried about it. We have a cast iron scientific foundation and a robust, comprehensive safety data profile for FDKP. Black box, no box, thousands of patients will soon be enjoying life more humann. Blockbuster (Martine today).
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Post by peppy on Feb 24, 2022 19:24:09 GMT -5
Mike said in the call (paraphrasing) that they put together such a comprehensive package that it became a major amendment to the NDA and he’s not worried about it. We have a cast iron scientific foundation and a robust, comprehensive safety data profile for FDKP. Black box, no box, thousands of patients will soon be enjoying life more humann. Blockbuster (Martine today). Mango, I read it initially, and got the gist. the extension. www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-B/section-314.60Can you tell me what was resubmitted for review? I saw it was something like 500 pages in response..... safety stuff? and..... Martine had a good quarter, she is looking forward to launching TeptT |
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Post by standup on Feb 24, 2022 21:20:09 GMT -5
So was today's price drop a result of the delay or the shelf offering? I'm leaning towards the shelf offering.
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Post by sportsrancho on Feb 24, 2022 21:26:32 GMT -5
So was today's price drop a result of the delay or the shelf offering? I'm leaning towards the shelf offering. I think the delay.. |
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Post by cretin11 on Feb 24, 2022 22:03:01 GMT -5
So was today's price drop a result of the delay or the shelf offering? I'm leaning towards the shelf offering. I think the delay.. Agree it was the delay, as the price drop happened hours before we heard about the shelf offering. |
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Post by standup on Feb 25, 2022 0:54:15 GMT -5
Agree it was the delay, as the price drop happened hours before we heard about the shelf offering. You don't think the cat was out of the bag prior to the formal announcement? There's a history to support prior knowledge. |
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Post by sweedee79 on Feb 25, 2022 1:00:18 GMT -5
It was both... The offering was anticipated... This just sucks!!!
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Post by sportsrancho on Feb 25, 2022 3:49:27 GMT -5
Agree it was the delay, as the price drop happened hours before we heard about the shelf offering. You don't think the cat was out of the bag prior to the formal announcement? There's a history to support prior knowledge. Good point. |
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Post by prcgorman2 on Feb 25, 2022 7:42:14 GMT -5
It was extremely bad news and we know the FDA cannot be trusted to be fair or quick and I feel a little bad that Martine is being treated so badly by them. I am not a trusting person even if you think I am because of my support for Dr. Castagna’s leadership as CEO. I honestly feel he’s done a good job and I am grateful for his efforts and his conservative nature when it comes to spending Mannkind’s money. I appreciate that he’s cautious enough to let things get settled before counting on the revenue. That is being fiscally responsible. But where my distrust is maybe too strong is with regard to how Afrezza and now perhaps Tyvaso DPI has been treated by the FDA. The 3rd CRL, the AdComm, the black box label, all of it has been horrible to Mannkind and the PWDs that have benefitted from Afrezza. I don’t know what will happen to Tyvaso DPI, but my confidence is very low that the end result from the FDA will simply be, “OK, we looked, you’re cool, carry on”. I am curious what Nate Pile’s advice is. For myself, I unwound a portion of my position and reinvested elsewhere. GLTALs.
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Post by peppy on Feb 25, 2022 7:47:57 GMT -5
So was today's price drop a result of the delay or the shelf offering? I'm leaning towards the shelf offering. UTHR did not have a shelf offering. Is your name Eileen ?  |
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Post by standup on Feb 25, 2022 9:23:35 GMT -5
So was today's price drop a result of the delay or the shelf offering? I'm leaning towards the shelf offering. UTHR did not have a shelf offering. Is your name Eileen ? No, today I'm identifying as a male not named Eileen. |
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Post by peppy on Feb 25, 2022 9:24:58 GMT -5
I had to, when I saw you were leaning.
Sorry.
It is a joke in my pocket, I am dying to use.
I didn't say it was a good one.
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Post by jkendra on Feb 25, 2022 9:32:55 GMT -5
It was extremely bad news and we know the FDA cannot be trusted to be fair or quick and I feel a little bad that Martine is being treated so badly by them. I am not a trusting person even if you think I am because of my support for Dr. Castagna’s leadership as CEO. I honestly feel he’s done a good job and I am grateful for his efforts and his conservative nature when it comes to spending Mannkind’s money. I appreciate that he’s cautious enough to let things get settled before counting on the revenue. That is being fiscally responsible. But where my distrust is maybe too strong is with regard to how Afrezza and now perhaps Tyvaso DPI has been treated by the FDA. The 3rd CRL, the AdComm, the black box label, all of it has been horrible to Mannkind and the PWDs that have benefitted from Afrezza. I don’t know what will happen to Tyvaso DPI, but my confidence is very low that the end result from the FDA will simply be, “OK, we looked, you’re cool, carry on”. I am curious what Nate Pile’s advice is. For myself, I unwound a portion of my position and reinvested elsewhere. GLTALs. When Tyvaso DPI gets approved and it's time for FDA decision #3 we can do it all over again    |
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Post by standup on Feb 25, 2022 9:49:13 GMT -5
I had to, when I saw you were leaning. Sorry. It is a joke in my pocket, I am dying to use. I didn't say it was a good one. Oh, a dad joke. It went right over my head! |
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