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Post by sayhey24 on May 6, 2022 15:26:00 GMT -5
I agree Casper. I've sensed that the entire delay process is the FDA looking for (weak but plausible) excuses to play for time so the litigation can play out. Just my hunch. Will someone please elaborate on the litigation theory and what exactly might be involved? I'm unclear. TYIA Here is the petition - they are claiming FDKP aka Technosphere is dangerous and should require more testing even though UTHR had no issues during their trials. On one hand it could be an attempt by Liquida to try and delay Tyvaso DPI but IMO the diabetes cartel is highly concerned that if Tyvaso DPI does not have a black box Mike will try and use it as justification to remove the black box from afrezza. Liquidia has no pull with the FDA but the Diabetes Cartel does. Someone go the attention of the FDA lawyers to raise questions resulting in the last CRL to UTHR. Hit the download button at www.regulations.gov/document/FDA-2021-P-0714-0001 |
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Post by boca1girl on May 7, 2022 7:49:21 GMT -5
No one suspects Martin S. Is behind the CP to injure MNKD and stick it to Al again? Looks like a repeat performance to me.
I wonder if we’ll ever find out who is behind the CP. I hope UTHR/MNKD are able to find out.
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Post by hellodolly on May 7, 2022 10:23:34 GMT -5
Will someone please elaborate on the litigation theory and what exactly might be involved? I'm unclear. TYIA Here is the petition - they are claiming FDKP aka Technosphere is dangerous and should require more testing even though UTHR had no issues during their trials. On one hand it could be an attempt by Liquida to try and delay Tyvaso DPI but IMO the diabetes cartel is highly concerned that if Tyvaso DPI does not have a black box Mike will try and use it as justification to remove the black box from afrezza. Liquidia has no pull with the FDA but the Diabetes Cartel does. Someone go the attention of the FDA lawyers to raise questions resulting in the last CRL to UTHR. Hit the download button at www.regulations.gov/document/FDA-2021-P-0714-0001Not a question but my thoughts: Dangerous? If so, why did the FDA approve Afrezza? Inhalation of an already approved molecule in commercial use for patients, with no other reported SAE's since its first launch and years after approval, is an attempt to reach out to anyone who doesn't know any better. At best, the source hopes for more delays...which I highly doubt based on what is already known. UTHR turning over a treasure trove of supporting documents to back up their claim...that their studies, along with years of work done by Al Mann and his team (pre-Afrezza approval) show that the TS platform is SAFE along with why the current language on the box was factually traced to smoking cigarettes by two trials participants (but an FDA requirement nonetheless) developing lung disease, should prove to be a strong argument by UTHR. Finally, it is well known in the industry why CPs are used and their dismal success rate has been discussed on this board. |
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Post by Deleted on May 7, 2022 11:58:15 GMT -5
I agree Casper. I've sensed that the entire delay process is the FDA looking for (weak but plausible) excuses to play for time so the litigation can play out. Just my hunch. Is the litigation expected to play out fully in the next couple of weeks anyway? Not sure what the FDA would be accomplishing with such a delay. Or are you suggesting the FDA is trying to simply help LQDA by delaying the approval, but if so, why would the FDA favor little LQDA over larger UTHR. Yes - The FDA encourages competition and will do everything to make that happen. They don't like when a drug has no price competition. The FDA did not like the lawsuit against LQDA (even though it could be warranted) along with UTHR buying a $105M PRV. They went into the DPI NDA with a magnifying glass to find any possible violation and they found one. Its amazing how they found a 3rd party vendor violation regarding Trepostinil yet they didn't stop production to fix the problem. |
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