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Post by akemp3000 on Dec 28, 2020 18:04:26 GMT -5
It ain't so. Martine Rothblatt just said so with $105M  |
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Post by apidistra on Dec 28, 2020 18:55:53 GMT -5
It ain't so. Martine Rothblatt just said so with $105M $105 million speaks! |
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Post by Deleted on Dec 28, 2020 20:38:05 GMT -5
I'm just curious what other Pharma UTHR purchased this voucher from. Anyone here know? I didn't see it named in the filing, but I may well have missed it. The company is Y-mAbs Therapeutics (YMAB) |
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Post by babaoriley on Dec 28, 2020 22:25:33 GMT -5
Wondering if Mannkind has evaluated this device for possible patent infringement. I would assume that they have but who knows. Not sure of the value of the patent on the device - seems a bit obvious. It’s technosphere where the lion’s share of value is. I assume they can use the voucher for any drug or resell it, if what they have planned with Trept hits a snag before they redeem the voucher. Or is it already too late for that? |
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Post by matt on Dec 29, 2020 8:48:28 GMT -5
Not sure, these aren't sold by the FDA but rather, UTHR bought a PRV from another bio who likely needed the cash. I was always under the impression that the FDA awarded these after meeting certain criteria and that they were transferable to anyone who ponied up the $$. Seeking clarification?? You are correct; FDA has the discretion to award priority review status to developers of drugs that meet certain criteria as an incentive to accelerate development of certain types of drugs, especially those with a market so small that the drug is not otherwise economically feasible. However, once issued, the voucher can be bartered or sold to a third-party and that is what has happened here. The math on this is pretty simple; somebody at UTHR believes that getting a new drug into the market four months earlier will generate a combination of additional sales revenue and a head start on any competitors that come along later. MNKD has found out how difficult it is to get endos to convert patients from one form of insulin to Afrezza, but don't think that pulmonologists behave any different than endocrinologists. If a physician has a number of patients on a particular drug, and dosing and side effect issues have already been addressed, they are extremely reluctant to switch the patients to something different. To answer the other question posed above, the normal cost for an FDA review is $250K if the drug is reviewed by the CDER (the traditional drug part of FDA) and $750K if the drug is reviewed by CBER (the biologic drug part of FDA). In the grand scheme of things, FDA user fees are not significant to the industry. The fact that UTHR is paying nine figures to short-cut the process by 120 days gives a strong hint about how much they think they can charge for the drug. This indication is not going to be cheap. |
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Post by peppy on Dec 29, 2020 9:03:06 GMT -5
Not sure, these aren't sold by the FDA but rather, UTHR bought a PRV from another bio who likely needed the cash. I was always under the impression that the FDA awarded these after meeting certain criteria and that they were transferable to anyone who ponied up the $$. Seeking clarification?? You are correct; FDA has the discretion to award priority review status to developers of drugs that meet certain criteria as an incentive to accelerate development of certain types of drugs, especially those with a market so small that the drug is not otherwise economically feasible. However, once issued, the voucher can be bartered or sold to a third-party and that is what has happened here. The math on this is pretty simple; somebody at UTHR believes that getting a new drug into the market four months earlier will generate a combination of additional sales revenue and a head start on any competitors that come along later. MNKD has found out how difficult it is to get endos to convert patients from one form of insulin to Afrezza, but don't think that pulmonologists behave any different than endocrinologists. If a physician has a number of patients on a particular drug, and dosing and side effect issues have already been addressed, they are extremely reluctant to switch the patients to something different.
To answer the other question posed above, the normal cost for an FDA review is $250K if the drug is reviewed by the CDER (the traditional drug part of FDA) and $750K if the drug is reviewed by CBER (the biologic drug part of FDA). In the grand scheme of things, FDA user fees are not significant to the industry. The fact that UTHR is paying nine figures to short-cut the process by 120 days gives a strong hint about how much they think they can charge for the drug. This indication is not going to be cheap. Question, what happens if the studies find the medication delivered by the dreamboat is superior? Can it be found superior? FULL PRESCRIBING INFORMATION Tyvaso® (treprostinil) inhalation solution For Oral Inhalation Only TYVASO (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). www.tyvaso.com/hcp/pdf/Tyvaso-PI.pdf |
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Post by myocat on Dec 29, 2020 9:06:17 GMT -5
With the Priority Review Voucher, it reduces the bearer to regulatory review in about six months rather than the standard ten months.
April 16, 2021 PDUFA has anything to do with this voucher?
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Post by harryx1 on Dec 29, 2020 10:49:14 GMT -5
I'm not sure it can get any clearer, Dr. Rothblatt has stated several times including putting it in company financial reports that if the 2 studies are successful and meet their endpoints, the FDA will approve Tyvaso DPI. They have obviously had discussions with the FDA and received this feedback. It's now even clearer, that by purchasing a PRV that she wants the product on the market ASAP and IMO signals that the BREEZE trial met all outcomes. She has also stated previously, several times, that they will move as many patients as possible to Tyvaso DPI when it hits the market. Comparing Afrezza to Tyvaso DPI is comparing apples and oranges in regards to their corresponding markets and indications. Tyvaso DPI is going to be sold and marketed by the leader in Trepostinil and we all know the story of Afrezza going up against an entrenched mob like insulin market. Tyvaso DPI will be the validation for Technosphere platform, leading to many more applications IMHO!  |
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Post by factspls88 on Dec 29, 2020 11:05:15 GMT -5
Agree.
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Post by morfu on Dec 29, 2020 12:48:31 GMT -5
This is good news, harryx1!
Let´s put my sinister suspicion upon who is selling millions of shares this week at this rather low price into a question: Is it possible to use the Mannkind ATM in a way that you put a big package of shares on the market ("100k shares at 3.50$ buy only complete") and your partner in crime is likely the only one bidding on it, since thanks to an ahead warning he/she is the only person ready for it? (My question is not about that anyone can sell and short this stock price, but if it is possible to make almost certain who gets the first bit on a large market priced share bundle)
As many readers in this forum know, I think the 20% dilution just before Christmas 2018 smelled fishy and I still want to know who got those shares, could something similar be happening in this week right before our eyes?
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Post by hellodolly on Dec 29, 2020 14:55:39 GMT -5
This is good news, harryx1!
Let´s put my sinister suspicion upon who is selling millions of shares this week at this rather low price into a question: Is it possible to use the Mannkind ATM in a way that you put a big package of shares on the market ("100k shares at 3.50$ buy only complete") and your partner in crime is likely the only one bidding on it, since thanks to an ahead warning he/she is the only person ready for it? (My question is not about that anyone can sell and short this stock price, but if it is possible to make almost certain who gets the first bit on a large market priced share bundle)
As many readers in this forum know, I think the 20% dilution just before Christmas 2018 smelled fishy and I still want to know who got those shares, could something similar be happening in this week right before our eyes?
Back door to recoup $1.05M dollars or at least share in the cost. If they believe MNKD SP will grow, which with payments and royalties aka revenue (Wall Streets favorite), they both may see the quid pro quo, in the formulas deal. |
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Post by Charlie on Dec 29, 2020 19:12:21 GMT -5
You are correct; FDA has the discretion to award priority review status to developers of drugs that meet certain criteria as an incentive to accelerate development of certain types of drugs, especially those with a market so small that the drug is not otherwise economically feasible. However, once issued, the voucher can be bartered or sold to a third-party and that is what has happened here. The math on this is pretty simple; somebody at UTHR believes that getting a new drug into the market four months earlier will generate a combination of additional sales revenue and a head start on any competitors that come along later. MNKD has found out how difficult it is to get endos to convert patients from one form of insulin to Afrezza, but don't think that pulmonologists behave any different than endocrinologists. If a physician has a number of patients on a particular drug, and dosing and side effect issues have already been addressed, they are extremely reluctant to switch the patients to something different.
To answer the other question posed above, the normal cost for an FDA review is $250K if the drug is reviewed by the CDER (the traditional drug part of FDA) and $750K if the drug is reviewed by CBER (the biologic drug part of FDA). In the grand scheme of things, FDA user fees are not significant to the industry. The fact that UTHR is paying nine figures to short-cut the process by 120 days gives a strong hint about how much they think they can charge for the drug. This indication is not going to be cheap. Question, what happens if the studies find the medication delivered by the dreamboat is superior? Can it be found superior? FULL PRESCRIBING INFORMATION Tyvaso® (treprostinil) inhalation solution For Oral Inhalation Only TYVASO (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). www.tyvaso.com/hcp/pdf/Tyvaso-PI.pdfMartine has a history of doing things that can't be done; making the impossible possible. She thrives on it. |
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Post by mango on Dec 30, 2020 15:18:37 GMT -5
Breeze clinical trial results most likely hit all endpoints.
UT is all in on TreT. $105M for a PRV isn’t couch change, even for a BP like UT.
All in.
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Post by agedhippie on Jan 1, 2021 13:47:29 GMT -5
Breeze clinical trial results most likely hit all endpoints. UT is all in on TreT. $105M for a PRV isn’t couch change, even for a BP like UT. All in. I definitely think UTHR is all in. My theory is that UTHR think they can delay Liquidia with the court case and want to get the conversion to TreT well underway by the time they lose in court. Matt's point about the difficulty in moving people is at the heart of this. Three months additional conversion time is a nice headstart, and once patients have swapped then getting them to swap again to Liquidia becomes incrementally harder. Basically, the standard BP playbook - use your financial muscle to squash the upstart (sound familiar?) Undoubtedly UTHR move this is good for MNKD though. |
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Post by uvula on Jan 1, 2021 17:29:37 GMT -5
By the time they lose in court
Or
If they lose in court?
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