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Post by nylefty on Oct 20, 2021 10:36:14 GMT -5
Sandoz is world wide. Itell? “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." The FDA could reinspect a test lab in just 2 weeks..so..if they take 8 months..I imagine many other elements may kick of before then...hmm. Maybe UTHR gets more of their products started on the DPI pathway.. The test lab that screwed up is now out of the picture, so it doesn't matter whem the FDA reinspects it. Castagna says that UTHR is now going to do its treprostinil testing in-house. "United Therapeutics will be moving the treprostinil testing to its own facility, Castagna said, and will file again with the FDA. The company originally filed its new drug application in April." |
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Post by sweedee79 on Oct 20, 2021 10:42:38 GMT -5
Yeah we still have to wait the 9 months ... People are blaming UT for this.. but this was caused by an OPEN inspection issue at the testing lab which obviously UT was never made aware of.. so I still call this FDA decision BS!!
The OPEN inspection issue at the test lab had nothing whatsoever to do with us..
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Post by Chris-C on Oct 20, 2021 11:01:29 GMT -5
If a third party person did screw up then the fda really had no choice but to delay approval. It sucks but we should be pissed at the person who is probably looking for a job and is having a much worse day than we are. Agreed. I hope that person has a lawyer. Intentionally falsifying data entries documenting quality control in FDA regulated labs may have legal consequences for the employee as individual. Not smart. |
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Post by celo on Oct 20, 2021 11:07:11 GMT -5
Could of purchased 20 whole labs for 100 million. Except, there would be an Open inspection issue with all 20 of them with the FDA.
8 months of thumb twiddling for something not based on DPI manufacturing or United or anything but a lab not having their shi! together. 8 months seems completely ridiculous for something totally out of mannkind or united's control.
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Post by sayhey24 on Oct 20, 2021 11:07:51 GMT -5
They did review the petition, they just did not complete the review. The petition is still open. It was not closed. If you look at the link below you can see what Lassman submitted. You can also see Lassman has not yet submitted any scientific data to substantiate their request. If and when they do the FDA can complete the review. Until then it will probably remain open. Do you think Lassman has any scientific data showing Tyvaso can cause ACUTE BRONCHOSPASM? I doubt it. Are there any reported cases for afrezza since approval? Mango would know but even if there are afrezza is not Tyvaso and there were none during the Tyvaso trials. In the CRL the FDA noted the petition. If additional data was going to be asked for based on the Lassman submission it would have as part of this CRL. If the FDA was requiring a boxed warning, it would have been part of the draft label. Here is the link - www.regulations.gov/search?filter=tyvaso%20dpiWell I think it should have been completed before our PDUFA date.. If Lassman hasn't submitted any scientific data by now it's probably because he doesn't have any... Because obviously it was just a ploy to cause a delay.. which I'm sure the FDA knows.. so why not just review it and close the matter before our PDUFA date? If the FDA closed it out, then that opens the door for Lassman to seek judicial intervention which then turns things into a big mess which could delay the approval. My guess is based on FDA questions UTHR had a heads up this was an issue which allowed them to plan to bring this function in house and to start preparing a new submission. I would also think UTHR provided Mike a heads-up which allowed him to pull the trigger on the additional financing with the lease-buy back. At the same time we now know what the label looks like which allowed UTHR to pull the trigger on the 10 year manufacturing deal. While the CRL is a delay, IMO its about the best CRL I have seen. Back in the day we had Al Mann trying to get human insulin approved and without forcing the Adcom it may never have gotten approved. |
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Post by sweedee79 on Oct 20, 2021 11:13:25 GMT -5
sayhey24So it sounds like the CP is what really held this up.. not just the test lab.. That makes more sense to me... New buyers coming in Thanks Sayhey!!!
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Post by sportsrancho on Oct 20, 2021 11:24:54 GMT -5
sayhey24 So it sounds like the CP is what really held this up.. not just the test lab.. That makes more sense to me... New buyers coming in Thanks Sayhey!!! I second that, makes a lot of sense❣️ |
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Post by Chris-C on Oct 20, 2021 11:29:02 GMT -5
I wonder what it feels like to work for a law firm that knowingly files “petitions” that pose as driven by public health concerns” when the real reason is business advantage? Ethical responsibility takes a back seat to greed every time. A person has got to wonder about what this says about the human species. No news here, really, but sad that it creeps into an agency set up to protect us all.
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Post by peppy on Oct 20, 2021 11:34:58 GMT -5
Well I think it should have been completed before our PDUFA date.. If Lassman hasn't submitted any scientific data by now it's probably because he doesn't have any... Because obviously it was just a ploy to cause a delay.. which I'm sure the FDA knows.. so why not just review it and close the matter before our PDUFA date? If the FDA closed it out, then that opens the door for Lassman to seek judicial intervention which then turns things into a big mess which could delay the approval. My guess is based on FDA questions UTHR had a heads up this was an issue which allowed them to plan to bring this function in house and to start preparing a new submission. I would also think UTHR provided Mike a heads-up which allowed him to pull the trigger on the additional financing with the lease-buy back. At the same time we now know what the label looks like which allowed UTHR to pull the trigger on the 10 year manufacturing deal. While the CRL is a delay, IMO its about the best CRL I have seen. Back in the day we had Al Mann trying to get human insulin approved and without forcing the Adcom it may never have gotten approved. So I understand, What is CRL? Sweetie, what is CP? (Darn it, another post.) |
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Post by gamblerjag on Oct 20, 2021 11:36:37 GMT -5
I wonder what it feels like to work for a law firm that knowingly files “petitions” that pose as driven by public health concerns” when the real reason is business advantage? Ethical responsibility takes a back seat to greed every time. A person has got to wonder about what this says about the human species. No news here, really, but sad that it creeps into an agency set up to protect us all. . Probably not much different than a defense attorney that defends somebody that killed a family of five and the police caught the accused with a gun in their hand in the house standing above the victims |
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Post by sweedee79 on Oct 20, 2021 11:40:44 GMT -5
If the FDA closed it out, then that opens the door for Lassman to seek judicial intervention which then turns things into a big mess which could delay the approval. My guess is based on FDA questions UTHR had a heads up this was an issue which allowed them to plan to bring this function in house and to start preparing a new submission. I would also think UTHR provided Mike a heads-up which allowed him to pull the trigger on the additional financing with the lease-buy back. At the same time we now know what the label looks like which allowed UTHR to pull the trigger on the 10 year manufacturing deal. While the CRL is a delay, IMO its about the best CRL I have seen. Back in the day we had Al Mann trying to get human insulin approved and without forcing the Adcom it may never have gotten approved. So I understand, What is CRL? Sweetie, what is CP? (Darn it, another post.) It's the citizens petition that was filed to delay approval
CRL is the complete response letter from FDA
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Post by boca1girl on Oct 20, 2021 12:16:06 GMT -5
sayhey24 So it sounds like the CP is what really held this up.. not just the test lab.. That makes more sense to me... New buyers coming in Thanks Sayhey!!! I think you may have misunderstood what Sayhey24 said about the CP. Leaving the CP open prevents the law firm, that filed the CP, from taking further legal action until a decision by the FDA is rendered. |
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Post by sweedee79 on Oct 20, 2021 12:18:11 GMT -5
sayhey24 So it sounds like the CP is what really held this up.. not just the test lab.. That makes more sense to me... New buyers coming in Thanks Sayhey!!! I think you may have misunderstood what Sayhey24 said about the CP. Leaving the CP open prevents the law firm, that filed the CP, from taking further legal action until a decision by the FDA is rendered. No I didn't misunderstand.. that's what I think!! |
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Post by harryx1 on Oct 20, 2021 12:37:48 GMT -5
Well I think it should have been completed before our PDUFA date.. If Lassman hasn't submitted any scientific data by now it's probably because he doesn't have any... Because obviously it was just a ploy to cause a delay.. which I'm sure the FDA knows.. so why not just review it and close the matter before our PDUFA date? If the FDA closed it out, then that opens the door for Lassman to seek judicial intervention which then turns things into a big mess which could delay the approval. My guess is based on FDA questions UTHR had a heads up this was an issue which allowed them to plan to bring this function in house and to start preparing a new submission. I would also think UTHR provided Mike a heads-up which allowed him to pull the trigger on the additional financing with the lease-buy back. At the same time we now know what the label looks like which allowed UTHR to pull the trigger on the 10 year manufacturing deal. While the CRL is a delay, IMO its about the best CRL I have seen. Back in the day we had Al Mann trying to get human insulin approved and without forcing the Adcom it may never have gotten approved. So wait a minute, you're saying that a group of people wanted to sabotage Tyvaso DPI from getting approved by creating an issue at a lab where Trepostinil is analyzed and filed a CP knowing that if Tyvaso DPI was approved or if the FDA closed out the CP then they could take further action by filing a lawsuit to delay the approval of Tyvaso DPI? That just can't be possible, that would neve happen in real life only in a movie...  |
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Post by sr71 on Oct 20, 2021 12:53:32 GMT -5
The movie "Mannkind - The Impossible Paradigm"
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