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Post by nylefty on Apr 12, 2021 15:24:53 GMT -5
Per the FDA's website: Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months ( compared to 10 months under standard review).So why has UTHR been saying they expect approval in December? That would be eight months from April, not six. Six months would be October.
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Post by Clement on Apr 12, 2021 15:46:19 GMT -5
Per the FDA's website: Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). So why has UTHR been saying they expect approval in December? That would be eight months from April, not six. Six months would be October. Check out this FDA webpage for yourself. www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020#priority-review"Priority Review A drug receives a Priority Review if CDER determines that the drug could potentially provide a significant advance in medical care. The drug is reviewed in an expedited time line: within eight months instead of the standard 12 months."
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Post by bones1026 on Apr 12, 2021 21:11:16 GMT -5
Hi Celo I should have worded the previous two messages differently. It is common knowledge in the public forum that UTHR will be spending 105 million dollars to expedite the approval of Tyvaso DPI. Approval can be received in 8 months as opposed to the normal 12 month time frame. From what I understand (I could be wrong) UTHR is spending this significant amount of money to simply have an additional 4 months to have their product(s) available for patients to make use of, prior to competitors similar products coming to market. In reality, the total loss incurred by UTHR in delaying their approval request is an unknown. The eight month time frame does not start until UTHR submits their request. Each and every week that UTHR delays in submitting their request, competitors gain an additional week to get their product(s) to market. I.M.H.O., we will see a significant increase in share price when UTHR makes the request to the FDA indicating they will be making use of MNKD to manufacture and provide the whistle to administer Tyvaso DPI. Please keep in mind, I have been wrong more times then not. L.O.L. Best of luck to all MNKD equity shareholders. It makes logical sense to me, but I question why the drastic raise in Shorts when they know about the voucher and submission? I hate to have to think perhaps we are being sandbagged again. Just a thought.. but is it possible the United knows of delays with being about to submit for approval, which would make the voucher more of a reaction to the know delay, and maybe shorts know that have a few more months before that significant spike in SP? I sure hope not, but this 7years has made me doubt everything and everyone related to MNKD
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Post by anderson on Apr 13, 2021 8:22:34 GMT -5
Looks like you are both correct in the timelines depending on if it is a NCE(new chemical entity) or NME(new molecular entity)
For a NDA for a NCE it is 6 months for priority and 10 months standard.
For a NDA for a NME it is 8 months for priority and 12 months standard.
I guess from this we can surmise that UTHR is having to use the NME route.
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Post by winner on Apr 18, 2021 8:04:20 GMT -5
Well folks,TEN business days have lapsed and still no Press Release. Maybe this will be the week.
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Post by Clement on Apr 18, 2021 19:32:54 GMT -5
Filing by end of April
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Post by boca1girl on Apr 19, 2021 7:39:13 GMT -5
Submitted today. When you say “filing by the end of April” do you mean that the FDA has accepted it for review?
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Post by akemp3000 on Apr 19, 2021 7:44:07 GMT -5
It's been filed. The next step is for the FDA to accept it and provide an estimated review completion date, most likely December.
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Post by Clement on Apr 19, 2021 8:29:31 GMT -5
Submitted today. When you say “filing by the end of April” do you mean that the FDA has accepted it for review? My post was yesterday (12 hours prior to your post) when I didn't know the New Drug Application would be submitted today. I can see how that was confusing. No, the FDA has not, as far as I know, accepted it for review. In the PR it says that that is the next step and I imagine that would be very soon. BTW, I appreciate your frequent posts.
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Post by neil36 on May 5, 2021 5:30:20 GMT -5
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Post by peppy on May 5, 2021 6:01:20 GMT -5
I see COPD.
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Post by derekewhitlock on May 5, 2021 8:35:05 GMT -5
UTHR rep just stated that UTHR has received from FDA, in writing, that if/when Tyvaso DPI is approved for PAH, all future approved indications of Tyvaso that are approved will automatically include approval of the Tyvaso DPI for the same subsequent indications.
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Post by boca1girl on May 5, 2021 8:42:49 GMT -5
From the above post, “potential T-DPI approval in December”, jumped out at me. I was expecting the approval in October since they submitted in April and were applying the 6 month “fast pass”. I believe many others may see this as a “delay” and have a one quarter delay in revenue recognition. I hope I’m wrong but I saw reference to this on ST.
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Post by jlaw277 on May 5, 2021 9:01:32 GMT -5
From the above post, “potential T-DPI approval in December”, jumped out at me. I was expecting the approval in October since they submitted in April and were applying the 6 month “fast pass”. I believe many others may see this as a “delay” and have a one quarter delay in revenue recognition. I hope I’m wrong but I saw reference to this on ST. SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). 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. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021. ir.unither.com/news/press-releases/press-release-details/2020/United-Therapeutics-Announces-Agreement-To-Acquire-Priority-Review-Voucher/default.aspx
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Post by nylefty on May 5, 2021 9:08:19 GMT -5
Looks like you are both correct in the timelines depending on if it is a NCE(new chemical entity) or NME(new molecular entity)
For a NDA for a NCE it is 6 months for priority and 10 months standard.
For a NDA for a NME it is 8 months for priority and 12 months standard.
I guess from this we can surmise that UTHR is having to use the NME route.
The above is the explanation for why it will probably be December.
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