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Post by longliner on Feb 26, 2021 1:41:23 GMT -5
Tying TIR to outcomes is still a work in progress. Right now the gold standard as far as the medical world is concerned is HbA1c, and until that changes the FDA will continue to use HbA1c. Right now there are no studies for TIR of the scale of UKDPS, DCCT, or any of the other mammoth studies. Time in range is logically the gold standard in diabetes care. To think otherwise is pure ...ignorance. If anybody would like to debate this, please do so. I can think of three BP's that will buy their way out of that standard (until they own it). I doubt (given BP balance sheets) that the FDA is all that expensive. |
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Post by celo on Feb 26, 2021 1:42:38 GMT -5
"For the year ended December 31, 2020, the Company sold an aggregate of 11,851,566 shares of the Company’s common stock at an average purchase price of $1.99 per share for an aggregate gross proceeds of approximately $23.5 million pursuant to the Sales Agreement."
That would explain the ending balance of 67 million. Mannkind can sell up to another approx. 25 million worth of stock. They have sold approx 25 million worth so far.
"The Company entered into a controlled equity offering sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, shares of the Company’s common stock having an aggregate offering price of up to $50.0 million or such other amount as may be permitted by the Sales Agreement. Under the Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an “at the market offering”
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Post by longliner on Feb 26, 2021 1:44:52 GMT -5
"For the year ended December 31, 2020, the Company sold an aggregate of 11,851,566 shares of the Company’s common stock at an average purchase price of $1.99 per share for an aggregate gross proceeds of approximately $23.5 million pursuant to the Sales Agreement." That would explain the ending balance of 67 million. Mannkind can sell up to another approx. 25 million worth of stock. They have sold approx 25 million worth so far. "The Company entered into a controlled equity offering sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, shares of the Company’s common stock having an aggregate offering price of up to $50.0 million or such other amount as may be permitted by the Sales Agreement. Under the Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an “at the market offering” That serves to mute our rise a bit. Oh well...gotta have cash. |
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Post by parrerob on Feb 26, 2021 3:15:04 GMT -5
sayhey24 - MC said that in 2020, MNKD worked on 5 formulations that were never announced, some of which were COVID related. He did not provide any more detail as to what they were or if they are still in the works. While the early indicators of the future for us is how many formulations we're working on. So we don't, we don't really disclose exactly who or what we're working with. We should know in 2020 we work on five different formulations s everal which were COVID related that we never announced, but we do know that we work in several therapeutic opportunities there and already in 2021 we have about 10 formulations on goal that we're working towards. Some of those have been completed. Some of those are in the process and many of these programs are partnered with external partners that we hope will turn into future business development deals that we'll announce later in 2021 and beyond
So not clear if the "many of these programs" are COVID related but seems like He could not detail more due to some disclosure.... |
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Post by akemp3000 on Feb 26, 2021 6:36:21 GMT -5
Makes sense. Mike has been consistent in only providing a press release when a formal partnership or material event occurs as is required. Beyond that he stays in Mannkind's lane and leaves the progress announcements and details up to the partner. This is likely in their partnership agreement. The exception to this would be the forty thousand foot overview of Mannkind's progress he provides in his slides. He doesn't share the details we'd like to hear but IMO that's intentional and also important for competitive reasons.
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Post by sayhey24 on Feb 26, 2021 7:18:06 GMT -5
Tying TIR to outcomes is still a work in progress. Right now the gold standard as far as the medical world is concerned is HbA1c, and until that changes the FDA will continue to use HbA1c. Right now there are no studies for TIR of the scale of UKDPS, DCCT, or any of the other mammoth studies. Time in range is logically the gold standard in diabetes care. To think otherwise is pure ...ignorance. If anybody would like to debate this, please do so. Hear Hear but its taking forever for all diabetics to augment their meters with CGMs. Until they see the numbers while they eat and see the effects they are just going to blindly go along with A1c. They just don't know any better and neither do many PCPs. I recently spoke with a newly minted resident out of UPenn and at first she thought I was nuts until she started validating what I was telling her. She might still think I am nuts but she now knows her training in diabetes was lacking. I don't know, maybe another 5 years until CGMs become ubiquitous. Five years ago I thought by now and Ollie Brandicourt thought 2021 would be the year of afrezza. I am hoping Ollie was right. I just keep waiting for Tim Cook and his non-invasive CGM watch. In the mean time Mike needs to keep pushing 2nd and 3rd dosing of afrezza and its minimal risk for severe hypos. He needs lots and lots of universities doing dosing studies. |
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Post by prcgorman2 on Feb 26, 2021 8:05:12 GMT -5
Safety, safety, safety. It’s the safety...
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Post by mango on Feb 26, 2021 8:39:06 GMT -5
FDA is not correlating TIR to outcomes. That is so *ucking absurd and ignorant. I’ve never witnessed such blatant ignorance and negligence by an agency in my life. We’ve been barking this chit for years here, but glucose homeostasis is assessed by TIR. It is the SINGLE MOST ACCURATE measurement of glucose homeostasis. I am LIVID! Tying TIR to outcomes is still a work in progress. Right now the gold standard as far as the medical world is concerned is HbA1c, and until that changes the FDA will continue to use HbA1c. Right now there are no studies for TIR of the scale of UKDPS, DCCT, or any of the other mammoth studies.  HbA1c is a proxy
 Time-in-range assesses glucose homeostasis   |
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Post by BD on Feb 26, 2021 8:51:31 GMT -5
He said last year there were 5 drugs they looked into that were not disclosed. This year there are 10 molecules they will be looking at. I was disappointed in the pediatric trial set up. EFFIN FDA will not consider time in range?!!!!!!!!!!!!! I hope i misheard that. FDA is not correlating TIR to outcomes. That is so *ucking absurd and ignorant. I’ve never witnessed such blatant ignorance and negligence by an agency in my life. We’ve been barking this chit for years here, but glucose homeostasis is assessed by TIR. It is the SINGLE MOST ACCURATE measurement of glucose homeostasis. I am LIVID! I have no idea what that means, but dammit, I'm livid too! |
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Post by uvula on Feb 26, 2021 9:17:39 GMT -5
FDA is not correlating TIR to outcomes. That is so *ucking absurd and ignorant. I’ve never witnessed such blatant ignorance and negligence by an agency in my life. We’ve been barking this chit for years here, but glucose homeostasis is assessed by TIR. It is the SINGLE MOST ACCURATE measurement of glucose homeostasis. I am LIVID! I have no idea what that means, but dammit, I'm livid too! (Welcome back old one!) Mango, aren't you upset with the wrong federal agency? The fda evaluates drugs for safety and efficacy. It doesn't give recommendations about which drug to use and doesn't establish standards of care. |
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Post by radgray68 on Feb 26, 2021 12:12:33 GMT -5
L I V I D = FURIOUSLY ANGRY...........great word to describe how I'm feeling now about the FDA. The FDA sets its own parameters and can decide to include whatever it wants.
It took me just one look at a CGM reading to understand the importance of time in range in diabetes therapy. ONE LOOK!!!!!!!!!!!
Sorry for the all caps but I can't shake the feeling we're going to get screwed again by the FDA. It's that thumping sensation in the rear that gives it away.
I'm making the face Andy DuFresne made to the warden when he says "How can you be so obtuse? Is it deliberate?" Unbelievable!!!
F _ _ _ !!!!!!!!!!!!!!!
ps. I hate getting pissed on a Friday so I'm going to try and remember all the good things going right with Mannkind. However, it's bourbon and coke tonight.
(Shuffling away Mumbling stupid FDA. How long you going to pee on the seat before you learn to put it up?)
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Post by BD on Feb 26, 2021 13:46:45 GMT -5
All caps are FINE in moderation!
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Post by mango on Feb 26, 2021 16:23:29 GMT -5
“MannKind 201 in idiopathic pulmonary fibrosis, which we are not disclosing for competitive reasons.” —Michael Castagna CEO MannKind Corp 2/25/21 MNKD-201 for Idiopathic Pulmonary Fibrosis—what is it? My guess? The Samumed small molecule that was specifically designed for inhalation for Idiopathic Pulmonary Fibrosis that targets the Wnt Pathway and was licensed to our partner, $UTHR Stay tuned, folks  |
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Post by mango on Feb 26, 2021 16:30:52 GMT -5
Afrezza Pediatric Phase 3 clinical trial commencing this year, folks.
Where is the excitement?!?
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Post by qwertqwert on Feb 26, 2021 16:57:06 GMT -5
“MannKind 201 in idiopathic pulmonary fibrosis, which we are not disclosing for competitive reasons.” —Michael Castagna CEO MannKind Corp 2/25/21 MNKD-201 for Idiopathic Pulmonary Fibrosis—what is it? My guess? The Samumed small molecule that was specifically designed for inhalation for Idiopathic Pulmonary Fibrosis that targets the Wnt Pathway and was licensed to our partner, $UTHR Stay tuned, folks This chart is filling in nicely, you couldn't say that a year ago. |
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