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Post by jkendra on Mar 2, 2022 22:01:42 GMT -5
The question that most interests me is. who is the client? Clients provide the money and the push to get lawyers to write these types of letters. Any ideas on how to find out who initiated this action? "Lassman Law+Policy is a boutique law firm located in Washington, D.C. that focuses on solving its clients’ most complicated FDA-related problems." This is the 1st sentence on the law firm's web site. Lassman isn't doing this for grins. Some entity with adverse interests to UTHR and MNKD is behind this. Yes, Scott Lassman is a paid organizer in an anticompetitive scheme against MannKind and United Therapeutics. I filed a FOIA request with FDA back in July 2021 requesting any and all information pertaining to the CP, including the locked information and the client. I followed up with them in September and was told by the Lead Regulatory Counsel got the Center for Drug Evaluation and Research that I should expect a response in 18-24 months. Yes, you read that right! Whether or not FDA will give me that information remains to be seen. Doesn’t hurt to ask, though. Further, FDA is used to these anticompetitive schemes, and this will not hold. It will not hold because FDA has already approved our technology and the data for Tyvaso DPI conflicts with Mr. Lassman’s assertions. If FDA is an agency that makes decisions based on scientific data and observations then they will dismiss the CP. It’s nothing more than a ploy to slow down the regulatory approval process and adds unnecessary time commitments and constraints on FDA employees to investigate a bogus CP. 11-17 months left ? 
What are the odds MannKind / United's second molecule goes through this also ?
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Post by robbmo on Mar 4, 2022 20:09:28 GMT -5
Yes, Scott Lassman is a paid organizer in an anticompetitive scheme against MannKind and United Therapeutics. I filed a FOIA request with FDA back in July 2021 requesting any and all information pertaining to the CP, including the locked information and the client. I followed up with them in September and was told by the Lead Regulatory Counsel got the Center for Drug Evaluation and Research that I should expect a response in 18-24 months. Yes, you read that right! Whether or not FDA will give me that information remains to be seen. Doesn’t hurt to ask, though. Further, FDA is used to these anticompetitive schemes, and this will not hold. It will not hold because FDA has already approved our technology and the data for Tyvaso DPI conflicts with Mr. Lassman’s assertions. If FDA is an agency that makes decisions based on scientific data and observations then they will dismiss the CP. It’s nothing more than a ploy to slow down the regulatory approval process and adds unnecessary time commitments and constraints on FDA employees to investigate a bogus CP. 11-17 months left ? 
What are the odds MannKind / United's second molecule goes through this also ?
My feeling is they submitted enough data and documentation to put this to bed for good, and unfortunately, it was so much that the FDA had to delay the PDUFA date to review it all. |
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Post by jkendra on Mar 5, 2022 8:57:46 GMT -5
11-17 months left ?
What are the odds MannKind / United's second molecule goes through this also ?
My feeling is they submitted enough data and documentation to put this to bed for good, and unfortunately, it was so much that the FDA had to delay the PDUFA date to review it all. Tyvaso DPI's efficacy and safety is so unbelievable that it needs to be delayed multiple times before it gets in the hands of any more patients ?  This must be some incredible technology. |
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Post by prcgorman2 on Mar 5, 2022 9:19:51 GMT -5
My feeling is they submitted enough data and documentation to put this to bed for good, and unfortunately, it was so much that the FDA had to delay the PDUFA date to review it all. Tyvaso DPI's efficacy and safety is so unbelievable that it needs to be delayed multiple times before it gets in the hands of any more patients ?  This must be some incredible technology. First delay was manufacturing issue (unrelated to Mannkind). Second delay was overwhelming response (we’re told) to lung safety question from the “citizen petition” (where the citizen is undoubtedly either a competitor or hedge fund manager wishing to short UTHR and/or MNKD). |
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Post by sportsrancho on Mar 5, 2022 10:40:34 GMT -5
Was it United or Mannkind that was responsible for hiring the third-party lab?
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Post by peppy on Mar 5, 2022 11:40:39 GMT -5
Was it United or Mannkind that was responsible for hiring the third-party lab? wow, ok, I'll answer this. TYVASO (treprostinil) is owned by United Therapeutics www.unither.com/productsRemodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.  |
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Post by mymann on Mar 5, 2022 12:22:16 GMT -5
Was it United or Mannkind that was responsible for hiring the third-party lab? What does it matter who hired the third party lab? The damage is done. |
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Post by cjm18 on Mar 5, 2022 12:42:18 GMT -5
My feeling is they submitted enough data and documentation to put this to bed for good, and unfortunately, it was so much that the FDA had to delay the PDUFA date to review it all. Tyvaso DPI's efficacy and safety is so unbelievable that it needs to be delayed multiple times before it gets in the hands of any more patients ? This must be some incredible technology. it’s not safe because there is a delay? The fda will determine that. Reviewing the data in days is not feasible. Maybe they don’t need 3 months but that’s probably the standard wait for nda amendments. The data submitted could determine whether there is a black box warning (one similar to Afrezza). Maybe mannkind can change their label should there be no bb warning for tyvaso dpi |
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Post by boca1girl on Mar 5, 2022 13:15:05 GMT -5
Was it United or Mannkind that was responsible for hiring the third-party lab? UTHR and UTHR fixed the problem by moving to another 3rd party or bringing it in-house. |
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Post by sportsrancho on Mar 5, 2022 13:44:57 GMT -5
Was it United or Mannkind that was responsible for hiring the third-party lab? What does it matter who hired the third party lab? The damage is done. I don’t know I only asked because I had an attorney who’s invested in Mannkind ask me. There’s so many confusing reports on this whole situation. There’s all kinds of questions because people aren’t sure which way it’s gonna go. |
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Post by jkendra on Mar 5, 2022 17:26:01 GMT -5
Tyvaso DPI's efficacy and safety is so unbelievable that it needs to be delayed multiple times before it gets in the hands of any more patients ? This must be some incredible technology. it’s not safe because there is a delay? The fda will determine that. Reviewing the data in days is not feasible. Maybe they don’t need 3 months but that’s probably the standard wait for nda amendments. The data submitted could determine whether there is a black box warning (one similar to Afrezza). Maybe mannkind can change their label should there be no bb warning for tyvaso dpi
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Post by helmut8056 on Mar 5, 2022 18:24:57 GMT -5
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.
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Post by cjm18 on Mar 5, 2022 19:49:56 GMT -5
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. That can change. We will find out in may. |
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Post by jkendra on Mar 5, 2022 20:07:19 GMT -5
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. That can change. We will find out in may.
What are the rules in this game ? Who is the referee ?
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Post by cjm18 on Mar 5, 2022 21:26:37 GMT -5
That can change. We will find out in may.
What are the rules in this game ? Who is the referee ?
The fda. |
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This must be some incredible technology.
This must be some incredible technology.
