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Post by harryx1 on Jul 14, 2021 10:00:15 GMT -5
The soon to-be-losers who have been relentlessly shorting MNKD see a clear and present danger ahead. Perhaps the unnamed client is Martin Shkreli? Or his cousin Vladimir. It’s fascinating that they are not concerned about Tyvaso, per se, only the DPI version. This tells you everything you need to know. I’ll be especially impressed when they post the FDA’s reply. My guess is this “letter” is for Stocktwits readers only. Most likely done by Liquidia and shorts working together as a counter attack to the lawsuit filed by UTHR. |
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Post by Clement on Jul 14, 2021 10:00:25 GMT -5
Is the one "client" Liquidia?
Mannkind has many years of experience with FDKP safety with Afrezza, so I cannot see this "citizen petition" going very far. Also, the patients in the completed BREEZE trial (Tyvaso DPI) have "compromised pulmonary function" and they got better, not worse.
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Post by harryx1 on Jul 14, 2021 10:15:43 GMT -5
FDKP is already an FDA approved excipient, so the petition should be a moot point. However LQDA's excipient has not been vigorously tested like FDKP. So hopefully UTHR will use this letter and submit the same for LQDA's excipient in LIQ861. www.sciencedirect.com/science/article/abs/pii/S014296121930674XFumaryl diketopiperazine (FDKP) is an inert excipient approved by the FDA for use as a carrier for inhalation formulations. FDKP has been successfully used as an effective carrier of Afrezza® to deliver insulin to the lung to improve its deposition efficiency [26,27]. Due to their carboxyl groups on side chains, FDKP can self-assemble to form microparticles at a lower pH environment (pH < 5) caused by a decrease in solubility. FDKP microparticles show negative charges on the surface produced by a dissociated carboxyl group which could attract proteins and other drugs with positive charges via electrostatic adherence [28]. In addition, with enhanced solubility at a neutral pH, FDKP could dissolve and absorb through the lung to be eliminated through the kidney in its original form [28]. As exhibited by an efficient aerosolization performance and good safety, FDKP has been considered as an excellent excipient for inhalation. Our previous research has indeed shown that FDKP microparticles can significantly improve the in vitro (fine particle fraction, FPF, 64.60 ± 0.41%) and in vivo (Cmax 4.25 ± 0.73%) deposition of small molecule drugs like AZM in lung tissues [29]. |
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Post by olderteampt on Jul 14, 2021 10:35:06 GMT -5
The question is not is it safe? The question is can the FDA be bought?
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Post by cedafuntennis on Jul 14, 2021 10:47:38 GMT -5
And the history shows us that it can and it has. Not sure about the 'bought' term but 'influenced' for sure...
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Post by sportsrancho on Jul 14, 2021 11:06:12 GMT -5
The concern is they could have to review it or delay the approval.
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Post by mango on Jul 14, 2021 11:36:10 GMT -5
FDA will completely dismiss the Citizen’s Petition. It is debunked due to the simple fact that it is already FDA approved and deemed a safe, inert particle. FDKP was required to undergo rigorous testing and was subjected to an extensive FDA review prior to FDA approval.
Honestly, the CP reads like a Looking For Diogenes hit piece and is a nothing burger.
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Post by prcgorman2 on Jul 14, 2021 12:00:53 GMT -5
5 minute walk test results for FDKP formulation and % of test subjects who wished to keep using it post-study says it all.
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Post by boca1girl on Jul 14, 2021 12:01:13 GMT -5
This petition sounds like Martin S. up to no good again.
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Post by jkendra on Jul 14, 2021 12:10:48 GMT -5
Can anything be done about a fraudulent citizen's petition ?
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Post by mango on Jul 14, 2021 12:11:05 GMT -5
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Post by peppy on Jul 14, 2021 12:42:37 GMT -5
Can anything be done about a fraudulent citizen's petition ? Citizen Petition. my understanding is the Supreme Court ruled, corporations are people too. Corporate personhood is the legal notion that a corporation, separately from its associated human beings (like owners, managers, or employees), has at least some of the legal rights and responsibilities enjoyed by natural persons. en.wikipedia.org/wiki/Corporate_personhood |
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Post by buyitonsale on Jul 14, 2021 14:13:23 GMT -5
Navigating to the site below and searching for "Tyvaso" brings up all related documents. There seems to be numerous documents related to Tyvaso over last 5 years (including other petitions and responses from FDA). www.regulations.gov/search?filter=tyvasoWhen selecting a filter of "Last 7 days" brings up the letter and the acknowledgment letter from FDA. You an then click to download the documents. |
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Post by factspls88 on Jul 14, 2021 14:16:40 GMT -5
Here we go again. Just when you thought it was safe to go back into the water.
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Post by peppy on Jul 14, 2021 14:32:05 GMT -5
Here we go again. Just when you thought it was safe to go back into the water. I think it is bologna and of no consequence. Here is what I believe. Superiority and clinical trial design. I think Maritine knows what she is doing. Then the 1.5 million spent to speed it up. |
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