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Post by ryster505 on Mar 1, 2022 14:59:40 GMT -5
Perhaps Matt is/was part of the team behind the Citizens Petition? Nothing would surprise me anyone around here…
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Post by esstan2001 on Mar 1, 2022 15:50:12 GMT -5
Strange (timing)...
John kastanas who used to post here and lists himself as a current long on SA just dropped an article that re-frames Afrezza as a conditionally approved FDA drug, MNKD as highly speculative, and in dire need of the safety trial to validate the exipient FKDP, hinting that Tyvaso approval is in jeopardy due to this having not been completed by a poorly managed strategy.
The presentation is very plausible to those unfamiliar.
Isn't the FDA usually fairly forgiving regarding timing?
So is this a) part of what appears to be a coordinates attack (and can xplain the current $ weakness) or b) have some validity...
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Post by mango on Mar 1, 2022 16:18:41 GMT -5
Strange (timing)...
John kastanas who used to post here and lists himself as a current long on SA just dropped an article that re-frames Afrezza as a conditionally approved FDA drug, MNKD as highly speculative, and in dire need of the safety trial to validate the exipient FKDP, hinting that Tyvaso approval is in jeopardy due to this having not been completed by a poorly managed strategy.
The presentation is very plausible to those unfamiliar.
Isn't the FDA usually fairly forgiving regarding timing?
So is this a) part of what appears to be a coordinates attack (and can xplain the current $ weakness) or b) have some validity...
Haha Hahaha You're kidding right? You just can't make this chit up can ya, John Cast Stains? |
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Post by phdedieu12 on Mar 1, 2022 16:33:18 GMT -5
And the reality is that there is always a chance Tyveso is not approved, then what?? How badly would that impact the company??
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Post by sportsrancho on Mar 1, 2022 16:36:10 GMT -5
Strange (timing)...
John kastanas who used to post here and lists himself as a current long on SA just dropped an article that re-frames Afrezza as a conditionally approved FDA drug, MNKD as highly speculative, and in dire need of the safety trial to validate the exipient FKDP, hinting that Tyvaso approval is in jeopardy due to this having not been completed by a poorly managed strategy.
The presentation is very plausible to those unfamiliar.
Isn't the FDA usually fairly forgiving regarding timing?
So is this a) part of what appears to be a coordinates attack (and can xplain the current $ weakness) or b) have some validity...
Another bankruptcy article. But yes they are forgiving regarding timing. I believe Mike tried to get out of it but they wouldn’t let him, it does need to get done. But nevertheless… 🤦🏼♀️ |
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Post by sportsrancho on Mar 1, 2022 16:37:16 GMT -5
And the reality is that there is always a chance Tyveso is not approved, then what?? How badly would that impact the company?? Horribly |
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Post by esstan2001 on Mar 1, 2022 16:38:37 GMT -5
And the reality is that there is always a chance Tyveso is not approved, then what?? How badly would that impact the company?? I don't know... we take our marbles and go home?
Nice of you to join this board along with the other recent adds, and it is great to get your take on this.
I know I feel better hearing lots of opinions... helps clear my thinking.
In timing, there are no coincidences.
Edit: And, OK I'll admit it- I'm now seeing conspiracy around every corner  |
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Post by harryx1 on Mar 1, 2022 16:57:58 GMT -5
IMHO, the rats & cockroaches have come out to play kick them while they are down... If Yutrepia can get approved with a fraction of safety studies and no long term safety studies and the amount of studies/trials done on Technosphere/FDKP, then again, either the FDA is corrupt or incompetent. And I'll keep calling them out on it for as long as I can.  image upload widget |
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Post by peppy on Mar 1, 2022 17:02:37 GMT -5
And the reality is that there is always a chance Tyveso is not approved, then what?? How badly would that impact the company?? Oct 18 (Reuters) - The U.S. Food and Drug Administration has declined to approve a lung disease therapy developed by United Therapeutics and Mannkind Corp, citing an inspection issue at a third-party facility. United said on Monday the health regulator's draft label for the drug, Tyvaso DPI, includes its use as a treatment for pulmonary arterial hypertension (PAH), as well as PAH associated with interstitial lung disease (PH-ILD). In its complete response letter, the agency did not cite any deficiencies related to operations at MannKind's device manufacturing and testing facility for Tyvaso DPI. -------------------------------------------------------------------------------------------------------------------------------------------------- The FDA's letter noted only a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance. 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."---- Why would the FDA decide to do that? With PAH, and PH-ILD the medication needs to get to the pulmonary veins. The way to get there is through the alveoli. Lqda uses the pulmonary endothelium. The bronchioles. A new submission.  |
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Post by cretin11 on Mar 1, 2022 17:33:58 GMT -5
And the reality is that there is always a chance Tyveso is not approved, then what?? How badly would that impact the company?? Horribly It’s a possibility most of us have wondered but we don’t like to acknowledge around these parts, so watch your back phdedieu. Just kidding (sort of). I do think the odds are greatly in our favor on Tyvaso approval. Of course, I felt the same thing about us getting that good word in Feb too. |
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Post by sportsrancho on Mar 1, 2022 17:37:12 GMT -5
It’s a possibility we don’t like to acknowledge around these parts, so watch your back phdedieu. Just kidding (sort of), and I think the odds are greatly in our favor on Tyvaso approval. Of course, I felt the same thing about us getting that good word in Feb too. Yeah I was gonna edit my post but then I got a phone call. I don’t see how we don’t get approval. It’s also important to make some major strides with Afrezza. |
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Post by akemp3000 on Mar 1, 2022 18:35:05 GMT -5
After the delay in October 2021, it was stated the FDA would make their decision by early summer 2022. Suddenly, it moved up to February and emotions ran high. Now it's back to where it originally started...early summer. Disappointed but not overly concerned. I believe Martine that it will happen.
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Post by phdedieu12 on Mar 1, 2022 22:54:48 GMT -5
And the reality is that there is always a chance Tyveso is not approved, then what?? How badly would that impact the company?? I don't know... we take our marbles and go home?
Nice of you to join this board along with the other recent adds, and it is great to get your take on this.
I know I feel better hearing lots of opinions... helps clear my thinking.
In timing, there are no coincidences.
Edit: And, OK I'll admit it- I'm now seeing conspiracy around every corner  I haven't been as long as most, and tend to enjoy the banter from afar. Like many, I believed, and still believe Tyveso should be approved, simply because the body of evidence support it. Existing drug, with existing approved delivery method seems like a pretty good combination, and both companies displaying confidence in their rollout. But there is little to no difference in the position we were in in October, and yet the sp is half what it was. One would even suggest we're further along with other assets and should be higher. I won't opine on whether or not Tyveso revenue was baked in the shared price then, but I do believe that this approval would highlight the efficacy of the MNKD delivery platform and technology and "open the door" to future partnership. The delays seem to have had the opposite effect, and I simply hope May brings some good news. I try not to think of shorts, FDA corruption or play armchair CEO and let common sense do its job. I'd like to think that I am reasonably well informed, and I think brighter days are ahead, but I have a pretty nice runway in front of me and a whole lot of shares..... |
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Post by sayhey24 on Mar 2, 2022 8:08:52 GMT -5
I don't know... we take our marbles and go home?
Nice of you to join this board along with the other recent adds, and it is great to get your take on this.
I know I feel better hearing lots of opinions... helps clear my thinking.
In timing, there are no coincidences.
Edit: And, OK I'll admit it- I'm now seeing conspiracy around every corner I haven't been as long as most, and tend to enjoy the banter from afar. Like many, I believed, and still believe Tyveso should be approved, simply because the body of evidence support it. Existing drug, with existing approved delivery method seems like a pretty good combination, and both companies displaying confidence in their rollout. But there is little to no difference in the position we were in in October, and yet the sp is half what it was. One would even suggest we're further along with other assets and should be higher. I won't opine on whether or not Tyveso revenue was baked in the shared price then, but I do believe that this approval would highlight the efficacy of the MNKD delivery platform and technology and "open the door" to future partnership. The delays seem to have had the opposite effect, and I simply hope May brings some good news. I try not to think of shorts, FDA corruption or play armchair CEO and let common sense do its job. I'd like to think that I am reasonably well informed, and I think brighter days are ahead, but I have a pretty nice runway in front of me and a whole lot of shares..... I was not overly surprised with this delay of Tyvaso but I will be if it gets delayed further. Martine is a pretty savvy CEO and understands the chess pieces being moved on the board. To answer your first question - at some point Tyvaso DPI will be approved. It will most likely be approved in May with the requirement for a phase 4 safety program but nothing is justifying a black box. If not, UTHR will be required to put a similar black box as afrezza which should have no impact of projected Tyvaso sales. The last possibility is they would be required to put a preapproval safety trial together which is highly unlikely but could delay things 2 years. I don't think this will be the case. In the mean time the trial with the kids is underway and afrezza should see approval later next year. Mike and his team are now starting to get more aggressive with the "Seeing is Believing" campaign. They need to start getting some large corporate GP practices believing after seeing and changing their protocols for T2 treatment. Mike said break even for afrezza is next year - we will see. If I were Mike I would be calling Joshua Davis today and I would try and get him into the kids trial. TV commercials with Joshua demonstrating "Seeing is Believing" as a T1 in the trial and saying Mannkind has insulin for $99 a month might get some attention. |
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Post by cretin11 on Mar 2, 2022 10:48:37 GMT -5
I try not to think of shorts, FDA corruption or play armchair CEO and let common sense do its job. I'd like to think that I am reasonably well informed, and I think brighter days are ahead, but I have a pretty nice runway in front of me and a whole lot of shares..... If I were Mike I would be calling Joshua Davis today and I would try and get him into the kids trial. TV commercials with Joshua demonstrating "Seeing is Believing" as a T1 in the trial and saying Mannkind has insulin for $99 a month might get some attention. This! That is a great idea and an obvious golden opportunity for much needed PR and positive attention. It should happen today. |
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