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Post by pbaumgarten on Apr 13, 2022 22:48:16 GMT -5
Be careful what you wish for. With the perceived corruption in the FDA, they may put a hold on all these drugs for 2 years till they force such an evaluation... I would not put it past them considering that the fox pays for guarding the chicken coop. I'd be more inclined to believe that the FDA will simply extrapolate from afrezza trial data and put the same black box warning and lung testing recommendations on the tyvaso DPI powder. |
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Post by mango on Apr 14, 2022 8:51:08 GMT -5
Be careful what you wish for. With the perceived corruption in the FDA, they may put a hold on all these drugs for 2 years till they force such an evaluation... I would not put it past them considering that the fox pays for guarding the chicken coop. I'd be more inclined to believe that the FDA will simply extrapolate from afrezza trial data and put the same black box warning and lung testing recommendations on the tyvaso DPI powder. Here's the thing. FDA can't ethically do that. If FDA is an agency of the highest scientific pursuit and ethical standards they won't. If they are an agency of corruption and greed then anything is possible. Let's be very clear—bronchospasm was observed ONLY in clinically diagnosed asthmatics who were actually UNCONTROLLED asthmatics during the trial. This means the participants were literally taken off their asthma medications during the trial which was a detrimental flaw design on MannKind's part. Should have never happened. Bronchospasm was never observed in COPD participants. It's been established that Afrezza has no more lung function decline than subq insulin and it is reversible, if it even happens, which we are seeing more and more patients report improved lung function with Afrezza use. Zero bronchospasm was observed in Tyvaso DPI studies. There is absolutely zero indication or concern for bronchospasm with Tyvaso DPI in PAH patients. FDA must follow the science and the science does not point to bronchospasm, and extrapolating from an irrelevant study conducted with a different drug in patients with uncontrolled asthma, and using that data for an unrelated drug and different disease where no cause for concern has been raised is not science. |
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Post by dh4mizzou on Apr 14, 2022 10:12:16 GMT -5
Sadly I've lost all thoughts that these government agencies would work in the best interests of the American people.
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Post by markado on Apr 14, 2022 12:55:04 GMT -5
Regulators don't like to have their decisions questioned, but, in the event of a questionable adverse decision, there's a process for it.
That said, I have been contemplating the possibility of a class action lawsuit on behalf of both companies and all their respective shareholders and potential patient bases, in the event of egregious and capricious treatment of the UTHR filing, or misuse of the data and the CP to somehow call into question MNKDs choice of particle.
Any CA attorneys out there care to weigh in?
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Post by prcgorman2 on Apr 15, 2022 5:39:47 GMT -5
I'd be more inclined to believe that the FDA will simply extrapolate from afrezza trial data and put the same black box warning and lung testing recommendations on the tyvaso DPI powder. Here's the thing. FDA can't ethically do that. If FDA is an agency of the highest scientific pursuit and ethical standards they won't. If they are an agency of corruption and greed then anything is possible. Let's be very clear—bronchospasm was observed ONLY in clinically diagnosed asthmatics who were actually UNCONTROLLED asthmatics during the trial. This means the participants were literally taken off their asthma medications during the trial which was a detrimental flaw design on MannKind's part. Should have never happened. Bronchospasm was never observed in COPD participants. It's been established that Afrezza has no more lung function decline than subq insulin and it is reversible, if it even happens, which we are seeing more and more patients report improved lung function with Afrezza use. Zero bronchospasm was observed in Tyvaso DPI studies. There is absolutely zero indication or concern for bronchospasm with Tyvaso DPI in PAH patients. FDA must follow the science and the science does not point to bronchospasm, and extrapolating from an irrelevant study conducted with a different drug in patients with uncontrolled asthma, and using that data for an unrelated drug and different disease where no cause for concern has been raised is not science. That is one great post. Thank you Mango. |
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Post by centralcoastinvestor on Apr 15, 2022 9:25:40 GMT -5
Here's the thing. FDA can't ethically do that. If FDA is an agency of the highest scientific pursuit and ethical standards they won't. If they are an agency of corruption and greed then anything is possible. Let's be very clear—bronchospasm was observed ONLY in clinically diagnosed asthmatics who were actually UNCONTROLLED asthmatics during the trial. This means the participants were literally taken off their asthma medications during the trial which was a detrimental flaw design on MannKind's part. Should have never happened. Bronchospasm was never observed in COPD participants. It's been established that Afrezza has no more lung function decline than subq insulin and it is reversible, if it even happens, which we are seeing more and more patients report improved lung function with Afrezza use. Zero bronchospasm was observed in Tyvaso DPI studies. There is absolutely zero indication or concern for bronchospasm with Tyvaso DPI in PAH patients. FDA must follow the science and the science does not point to bronchospasm, and extrapolating from an irrelevant study conducted with a different drug in patients with uncontrolled asthma, and using that data for an unrelated drug and different disease where no cause for concern has been raised is not science. That is one great post. Thank you Mango. I concur. Great post. |
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