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Post by goyocafe on Jun 16, 2021 7:42:12 GMT -5
Is FDA reviewing the Afrezza black box warning and PFT requirement? Would be great to get rid of those, but I don’t recall any news along those lines. MC indicated recently they were working with FDA on making the spirometry optional instead of required. Afrezza BBW has nothing to do with Tyvaso and likely will not be affected by it. So bronchospasms only occurred during Afrezza studies? Just playing devil’s advocate, but I would find it curious that they don’t occur with all compounds. |
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Post by mango on Jun 16, 2021 8:00:20 GMT -5
MC indicated recently they were working with FDA on making the spirometry optional instead of required. Afrezza BBW has nothing to do with Tyvaso and likely will not be affected by it. So bronchospasms only occurred during Afrezza studies? Just playing devil’s advocate, but I would find it curious that they don’t occur with all compounds. Unless bronchospasms was significant in the Tyvaso DPI clinical trials then, no, it will not be an issue. There has been absolutely no indication that has been the case with Tyvaso DPI. |
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Post by wesnigon on Jun 16, 2021 8:00:56 GMT -5
Nice to see MNKD mentioned in the UTHR press release.
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Post by lennymnkd on Jun 16, 2021 8:07:04 GMT -5
How could they not !
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Post by cjm18 on Jun 16, 2021 8:17:38 GMT -5
FDA review expected to be complete in October 2021
Is this 2 months earlier than expected? Or is it still going to be approved in December?
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Post by sportsrancho on Jun 16, 2021 8:24:37 GMT -5
FDA review expected to be complete in October 2021 Is this 2 months earlier than expected? Or is it still going to be approved in December? Sounds like it’s earlier than expected. 💃 |
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Post by Clement on Jun 16, 2021 8:37:02 GMT -5
FDA review expected to be complete in October 2021 Is this 2 months earlier than expected? Or is it still going to be approved in December? Sounds like it’s earlier than expected. 💃 Only 4 months from now! |
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Post by anderson on Jun 16, 2021 9:14:05 GMT -5
FDA review expected to be complete in October 2021 Is this 2 months earlier than expected? Or is it still going to be approved in December? The October 'Review' finished date may be a bait and switch.
I think everyone needs to look at www.fda.gov/media/78941/download and see that 'Review' is a phase of the FDA approval(look at the appendix A for NME timeline). There is the 'Take Action' phase after, which for priority looks like it is 5 weeks. What we want to hear is what is the PDUFA date, which is most likely early December or late November approval date that was stated in previous press releases.
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Post by harryx1 on Jun 16, 2021 9:30:47 GMT -5
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Post by mango on Jun 16, 2021 9:44:18 GMT -5
Next major milestone in the approval of Tyvaso DPI hinges on a successful FDA inspection of the MannKind award winning, state-of-the-art manufacturing facility in Danbury, CT.
MannKind currently has a 100% passing rate with FDA inspections.
I have the utmost confidence MannKind will pass this FDA inspection in Q3 with ease.
Upon successful FDA approval of Tyvaso DPI, MannKind will receive both low double-digit royalties (projected to be >$100M by 2024) as well as manufacturing margins.
It’s a great time to be a MannKind Long.
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Post by anderson on Jun 16, 2021 9:56:23 GMT -5
I really hope that calendar is correct harryx1.
Which uses more precise language than the MNKD one "FDA action expected in October 2021" so it looks like it is a October surprise.
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Post by longliner on Jun 16, 2021 10:22:02 GMT -5
October! “which is expected to be complete in October 2021. The FDA has also indicated that they have not identified any potential review issues at this time.” Congratulations longs! F/U shorts. |
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Post by mango on Jun 16, 2021 10:46:53 GMT -5
There has not been an official PDUFA date announced yet. I suspect we will find out the exact date relatively soon.
Right now MannKind’s primary focus is preparing for FDA inspection. They have already been preparing for this per MC in pervious CCs.
They will pass, FDA will approve Tyvaso DPI, and a second collaboration announcement between MannKind and UT will be announced.
This is the beginning of great things. Patience is key.
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Post by boca1girl on Jun 16, 2021 12:23:12 GMT -5
The FDA has already reviewed the submission and said there were no deficiencies.
Mannkind already has the production line up and running and provided the clinical test supply.
If MNKD/FDA can schedule the facility inspection in early 3Q, what will the FDA be doing until October 15?
I know, no one can answer the question, but if I was running the FDA, I would be looking to streamline product approvals for an existing FDA approved drug, manufactured by a FDA approved manufacturer, using an a FDA approved delivery system.
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Post by mytakeonit on Jun 16, 2021 12:44:02 GMT -5
The big question is ... did everyone buy all the cheap shares they could? Volume is picking up and you probably have today to do it ... if you haven't already.
We're going to the moon Alice !!!
But, that's mytakeonit
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