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Post by cppoly on Jul 2, 2020 9:36:20 GMT -5
Having a hard time finding this info. I checked Mannkind's website but it doesn't list expected completion dates of their products on the Pipeline page. Google searches aren't helping either (and sending me down too many rabbit holes...).
When is Phase 3 expected to be completed?
Would it be a reasonable suggestion for Mannkind to put expected completion dates for the current phases of their products on their website?
Thanks
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Post by harryx1 on Jul 2, 2020 9:42:21 GMT -5
clinicaltrials.gov/ct2/show/NCT03950739Expected trial to be completed by August 2020, 2-3 months to compile data from trial IMO. Submit NDA by UTHR somewhere in Nov-Jan. UTHR has already stated that the FDA will approve application if BREEZE (Safety & Tolerability) trial is successful. Some argue that TreT won't be approved until late 2021 but IMO I think it will be 1H 2021 w/ commercialization early 2H 2021 maybe even late 1H 2021. All in my opinion. mnkd.proboards.com/post/207304
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Post by matt on Jul 2, 2020 10:15:20 GMT -5
Would it be a reasonable suggestion for Mannkind to put expected completion dates for the current phases of their products on their website? That is a difficult thing to do with pipeline drugs. Firstly, TreT is not Mannkind's drug, it is UTHR's drug and just because a company has out-licensed a drug delivery technology that does not give it the right to control the development priorities of the other company. UTHR might, or might not, be fussy about what the label copy says and if the FDA does not want to give UTHR the label they want/need based on the current trial, they may want to do a second trial and that is their decision to make. For most other drugs, Mannkind is shopping for a commercialization partner and it is very hard to put dates to the conclusion of that search. Even if a partner can be found for each of the drugs, it will then be up to the partner to control the research process. Just because Mannkind is eager to enjoy some royalty revenue does not mean that such a project is at the top of the partner's to-do list. The larger the partner the more ability they have to process multiple developmental drugs in parallel so a lot depends on who the partner is. As for timing on TreT, I can't disagree with the previous comment by harryx1. Normally when an already approved drug is simply reformulated into a new delivery form, the process of getting that new formulation approved is relatively straightforward. The key with TreT is to show that results of inhaled delivery are similar to already approved methods, and that the delivered dose can be accurately predicted which can sometimes be tricky with an inhaled formulation. If the data from the Breeze study can strongly demonstrate dosing equivalency, then I think late 2021 / early 2022 market launch is realistic. If FDA is not happy with the data or requires an expanded trial, all bets are off. |
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Post by seanismorris on Jul 2, 2020 10:24:11 GMT -5
Expectations lead to disappointment.
For example, I expected the Afrezza pediatric study to be completed years ago.
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Post by mango on Jul 2, 2020 10:24:15 GMT -5
Mike and United Therapeutics has said multiple times in calls that they expect COVID-19 to not significantly impact the TreT clinical trial timelines, and that they expect to file with FDA in either Q4 2020 or Q1 2021.
If they get TreT fast tracked then FDA will make the approval in ~6 weeks or within 60 days. If they get TreT in Priority Review, FDA will approve it in ~6 months.
There is also breakthrough therapy approval and accelerated approval. Personally, I believe it will be fast tracked.
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Post by harryx1 on Jul 2, 2020 10:39:30 GMT -5
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Post by prcgorman2 on Jul 2, 2020 11:15:24 GMT -5
Expectations lead to disappointment. For example, I expected the Afrezza pediatric study to be completed years ago. Your post did not dissapoint. It is exactly what I expect from you. |
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