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Post by porkini on Jan 28, 2021 12:01:30 GMT -5
NDA submission in April. Approval in October 2021? I would say FDA Approval is 4Q21. I think Oct. is a little early. ? ? ? Oct Nov Dec = 4Q ? ? ?
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Post by kite on Jan 28, 2021 12:06:33 GMT -5
I would say FDA Approval is 4Q21. I think Oct. is a little early. ? ? ? Oct Nov Dec = 4Q ? ? ? Yes, it would be fantastic if approval came before the end of 2021!
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Post by helmut8056 on Jan 28, 2021 12:11:04 GMT -5
What happened to the 100 + mil. to expedite?
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Post by Clement on Jan 28, 2021 12:16:09 GMT -5
What happened to the 100 + mil. to expedite? Look in the press release: "United Therapeutics intends to submit a New Drug Application (NDA) to the FDA for Tyvaso DPI for indications covering PAH and pulmonary hypertension associated with interstitial lung disease in April 2021 and plans to apply a priority review voucher to the Tyvaso DPI NDA, providing an expedited FDA review period."
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Post by mytakeonit on Jan 28, 2021 13:46:32 GMT -5
Do you all still think you have enough MNKD shares?
But, that's mytakeonit
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Post by kite on Jan 28, 2021 13:55:20 GMT -5
Do you all still think you have enough MNKD shares? But, that's mytakeonit Never enough!
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Post by mango on Jan 28, 2021 18:44:12 GMT -5
Approval should be in October if they file in April. In Priority Review FDA takes action on an application within 6 months.
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Post by goyocafe on Jan 28, 2021 18:47:30 GMT -5
Approval should be in October if they file in April. In Priority Review FDA takes action on an application within 6 months. Let's hope that any slow down related to Covid-19 doesn't interfere with the priority review. That would be a total waste.
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Post by harryx1 on Feb 1, 2021 13:54:10 GMT -5
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Post by buyitonsale on Feb 1, 2021 14:06:25 GMT -5
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Post by harryx1 on Feb 1, 2021 14:30:47 GMT -5
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Post by celo on Feb 1, 2021 14:31:12 GMT -5
"After three weeks of treatment, these patients showed improved exercise capacity, reduced patient-reported PAH symptoms and impact" This is over taking tyvaso through a nebulizer? I mean, these patients went right from the nebulizer to the Mannkind inhaler and then had improvement. Tyvaso is already a well liked medication and now it has improvement.
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Post by celo on Feb 20, 2021 15:54:36 GMT -5
Approval should be in October if they file in April. In Priority Review FDA takes action on an application within 6 months. From what I read when United received the voucher, the review will now take 8 months instead of 12. If filed in April, then completed in December 2021. Where does the 6 month timeline come from? "The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period." seekingalpha.com/pr/18134467-united-therapeutics-announces-agreement-to-acquire-priority-review-voucher
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Post by celo on Feb 20, 2021 21:39:22 GMT -5
I toast tonight to Al Mann and Martine Rothblatt. Two of the greatest people of all time. Incredible thinkers outside of the box. Unbelievable ability to see a specific need and then be able to create something entirely new to fill that need.
We as a society owe such a huge debt of gratitude to these individuals.
Looking forward to this week and the annual reports.
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Post by celo on Feb 24, 2021 9:14:57 GMT -5
Transition will be swift to DPI. Prescribing doctors are excited with use!
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