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Post by mango on Dec 28, 2020 9:12:52 GMT -5
This means we will obtain FDA approval in 2021 and launch in Q1 2022.
2021 is shaping up to being our best year ever.
✅ Sumatriptan Phase 1 initiation
✅ Clofazimine Phase 1 initiation
✅ TreT FDA approval
✅ Thyquidity co-promote
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Post by letitride on Dec 28, 2020 9:13:10 GMT -5
Just say Blam.
Lets Go!
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Post by uvula on Dec 28, 2020 9:27:53 GMT -5
If a company has to pay this much to speed things up a little bit, how much does a company pay the FDA to review a NDA? It sounds like extortion to get the FDA to do its job. Not really......Selling PRVs are pretty common. Think about it...if a company is granted a PRV that means they have a good drug in trials but there are times when the drug fails and the company has a useless voucher so they see if there's a market for it. Willing SELLER Willing BUYER. That makes a market. Seems Legit. Legit but the process seems sleazy. If a company has a drug for a Rare Pediatric Disease they can get a "Rare Pediatric Disease Priority Review Voucher" directly from the FDA (presumably without a huge payment). This sounds fine. If UTHR has a drug for a Rare Pediatric Disease, why can't they get a voucher directly from the FDA? If the voucher is rare (i.e. limited supply), how are they given out? Is it random, based on need, or based on cozy big pharm relationships? If the original company can't use the voucher, shouldn't it be returned to the FDA so the FDA can give it to someone else? This is almost like someone on a kidney transplant list selling their spot to someone else. This is good for UTHR or they would not have done the deal. But it would be interesting to know more about how the process works. |
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Post by uvula on Dec 28, 2020 9:36:47 GMT -5
Why is UTHR share price down a little bit so far today?
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Post by boca1girl on Dec 28, 2020 9:45:13 GMT -5
FWIW, Yahoo Finance and TD Ameritrade are not showing this as "News" under MNKD stock symbol. MNKD should be a strong buy now for the early birds catching this news before the others figure it out. JMHO. It's not news from MNKD. Seeking Alpha shows it as news for MNKD. Why wouldn’t it be news for MNKD, who is a partner on the drug? The Dreamboat inhaler is mentioned in the news release. |
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Post by agedhippie on Dec 28, 2020 9:51:33 GMT -5
Why is UTHR share price down a little bit so far today? Because they just blew $100M and until that is shown to be a good idea UTHR will be penalized for it. This is positive for MNKD and YMAB. |
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Post by yash on Dec 28, 2020 9:58:14 GMT -5
Not really......Selling PRVs are pretty common. Think about it...if a company is granted a PRV that means they have a good drug in trials but there are times when the drug fails and the company has a useless voucher so they see if there's a market for it. Willing SELLER Willing BUYER. That makes a market. Seems Legit. Legit but the process seems sleazy. If a company has a drug for a Rare Pediatric Disease they can get a "Rare Pediatric Disease Priority Review Voucher" directly from the FDA (presumably without a huge payment). This sounds fine. If UTHR has a drug for a Rare Pediatric Disease, why can't they get a voucher directly from the FDA? If the voucher is rare (i.e. limited supply), how are they given out? Is it random, based on need, or based on cozy big pharm relationships? If the original company can't use the voucher, shouldn't it be returned to the FDA so the FDA can give it to someone else? This is almost like someone on a kidney transplant list selling their spot to someone else. This is good for UTHR or they would not have done the deal. But it would be interesting to know more about how the process works. Y-mAbs Announces Sale of Priority Review Voucher NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has entered into a definitive agreement to sell its Priority Review Voucher (“PRV”) to United Therapeutics Corporation (Nasdaq: UTHR), based on an agreed valuation of $105 million. |
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Post by mnkdfann on Dec 28, 2020 10:00:40 GMT -5
Not really......Selling PRVs are pretty common. Think about it...if a company is granted a PRV that means they have a good drug in trials but there are times when the drug fails and the company has a useless voucher so they see if there's a market for it. Willing SELLER Willing BUYER. That makes a market. Seems Legit. Legit but the process seems sleazy. If a company has a drug for a Rare Pediatric Disease they can get a "Rare Pediatric Disease Priority Review Voucher" directly from the FDA (presumably without a huge payment). This sounds fine. If UTHR has a drug for a Rare Pediatric Disease, why can't they get a voucher directly from the FDA? If the voucher is rare (i.e. limited supply), how are they given out? Is it random, based on need, or based on cozy big pharm relationships? If the original company can't use the voucher, shouldn't it be returned to the FDA so the FDA can give it to someone else? This is almost like someone on a kidney transplant list selling their spot to someone else. This is good for UTHR or they would not have done the deal. But it would be interesting to know more about how the process works. |
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Post by geomean on Dec 28, 2020 11:13:15 GMT -5
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Post by goyocafe on Dec 28, 2020 11:16:04 GMT -5
Does this possibly suggest that UTHR has in its possession the study results we’re all waiting for? It’s a big purchase and you wouldn’t commit to something like this if you weren’t pretty darn sure of a positive review by the FDA.
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Post by Clement on Dec 28, 2020 11:25:02 GMT -5
Does this possibly suggest that UTHR has in its possession the study results we’re all waiting for? It’s a big purchase and you wouldn’t commit to something like this if you weren’t pretty darn sure of a positive review by the FDA. I agree, especially in light of the latest clinicaltrials.gov update last week. |
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Post by radgray68 on Dec 28, 2020 12:39:33 GMT -5
this does beg the question: How freakin good are those trial results that they are willing to spend over a $100 mil just to speed up the process? I mean holy cow! Great partner!
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Post by kc on Dec 28, 2020 12:41:31 GMT -5
They must think its going to be a REALLY BIG PRODUCT TO PAY THAT KIND OF MONEY FOR THE FAST PATH....
Pretty exciting.
United Therapeutics to acquire priority review voucher for $105M
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Post by kc on Dec 28, 2020 12:42:35 GMT -5
They should have spent the $105 million buying an interest in MannKind.....
United Therapeutics to acquire priority review voucher for $105M
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Post by porkini on Dec 28, 2020 12:49:50 GMT -5
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