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Post by buyitonsale on Jun 16, 2021 12:52:38 GMT -5
I hope we can get the official PDUFA date soon, I emailed UTHR IR regarding that... will post if I hear back.
But I think they would not mention October if FDA did not indicate that in the acceptance letter...
It is just one surprise after another, what a great partner UTHR has been so far!
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Post by buyitonsale on Jun 16, 2021 13:00:04 GMT -5
Just got a response from UTHR IR: "Hi – the PDUFA date is in October. We have not (and will not) give the exact PDUFA date." I will assume around 20th of October  Longs don't need luck! |
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Post by lazyb767 on Jun 16, 2021 13:32:09 GMT -5
The FDA has already reviewed the submission and said there were no deficiencies. Mannkind already has the production line up and running and provided the clinical test supply. If MNKD/FDA can schedule the facility inspection in early 3Q, what will the FDA be doing until October 15? I know, no one can answer the question, but if I was running the FDA, I would be looking to streamline product approvals for an existing FDA approved drug, manufactured by a FDA approved manufacturer, using an a FDA approved delivery system. You don't sound like a government employee, at all. Just sayin.  |
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Post by mango on Jun 16, 2021 13:38:50 GMT -5
Just got a response from UTHR IR: "Hi – the PDUFA date is in October. We have not (and will not) give the exact PDUFA date." I will assume around 20th of October Longs don't need luck! Nice. |
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Post by mango on Jun 16, 2021 13:48:47 GMT -5
Ya’ll know what this means right?
ROYALTIES BEGIN THIS YEAR.
MannKind becomes profitable next year.
Remember Martine said around 70% of current Tyvaso users will convert over to Tyvaso DPI within the 4 months post-FDA approval. We will have NICE royalties streaming in during Q1 2022.
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Post by Deleted on Jun 16, 2021 13:53:51 GMT -5
Just got a response from UTHR IR: "Hi – the PDUFA date is in October. We have not (and will not) give the exact PDUFA date." I will assume around 20th of October Longs don't need luck! The FDA will issue the PDUFA Date. |
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Post by akemp3000 on Jun 16, 2021 14:10:32 GMT -5
Moving the PDUFA date up to October 15 means moving advanced product production up early which means moving UTHR manufacturing revenues paid to Mannkind up early. New revenue means the time frame for the shorting game also moves up early BTW, thanks Harry for posting the FDA calendar. I've been tracking the FDA calendar for years and its rare that the announced PDUFA dates changes. One exception is when the FDA issues an early CRL for a "new" drug and the PDUFA date is then removed which thankfully isn't the case here. It's not so rare that the FDA might even surprise with an early decision. Just saw the UTHR IR update stating they don't announce the PDUFA date. Fortunately, the FDA does and their calendar apparently now shows it. |
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Post by buyitonsale on Jun 16, 2021 14:41:08 GMT -5
Based on UTHR IR comment "the PDUFA date is in October.", I assume that FDA did issue it and communicated to UTHR, but UTHR is not reporting it for whatever reason. Maybe on the FDA website, there will be a way to look it up... The calendar posted in this thread today is not from FDA, it is from an investment website and is based on company reports. The dates are estimates... www.biopharmcatalyst.com/calendars/pdufa-calendar |
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Post by akemp3000 on Jun 16, 2021 15:29:32 GMT -5
See Harry's post in this thread that shows the FDA's PDUFA calendar and the October 15 date for UTHR and MNKD. Coming soon!
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Post by factspls88 on Jun 16, 2021 15:52:16 GMT -5
Just got a response from UTHR IR: "Hi – the PDUFA date is in October. We have not (and will not) give the exact PDUFA date." I will assume around 20th of October Longs don't need luck! Nice! Thank you. |
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Post by buyitonsale on Jun 16, 2021 16:20:16 GMT -5
See Harry's post in this thread that shows the FDA's PDUFA calendar and the October 15 date for UTHR and MNKD. Coming soon! That is an investment website that compiles all announcements from biotech companies, not an official FDA calendar. October 15 is an estimate. All we know is that it is in October. See my post above. |
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Post by akemp3000 on Jun 17, 2021 6:09:09 GMT -5
See Harry's post in this thread that shows the FDA's PDUFA calendar and the October 15 date for UTHR and MNKD. Coming soon! That is an investment website that compiles all announcements from biotech companies, not an official FDA calendar. October 15 is an estimate. All we know is that it is in October. See my post above. I've tracked and used this calendar for many years and it has been spot on accurate. It doesn't seem plausible that the source would make up and publish a specific date without a solid basis. The exact day isn't really that important as any day in October will be a big win for Mannkind. Hopefully the FDA will surprise us all with an early decision. GL |
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Post by sla55 on Jun 17, 2021 6:55:51 GMT -5
investors.mannkindcorp.com/static-files/b25b4587-86d1-4e0a-852b-2e851f9d149dForm 8-K: Item 8.01 Other Events. On June 16, 2021, MannKind Corporation (“MannKind”) and United Therapeutics Corporation (“United Therapeutics”) announced that the U.S. Food and Drug Administration (“FDA”) accepted for priority review the New Drug Application (“NDA”) submitted by United Therapeutics for Tyvaso DPITM (inhaled treprostinil) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The development marks the second compound formulated with MannKind’s Technosphere® technology to be reviewed by the FDA, which is expected to be complete in October 2021. The FDA has also indicated that they have not identified any potential review issues at this time. A next-generation formulation of treprostinil, Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder, which was approved by the FDA in 2014. MannKind and United Therapeutics are also developing BluHale®, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use. MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI. In its communications with United Therapeutics, the FDA indicated that approval of the NDA will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind; the FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection. MannKind is entering an expansion phase as it prepares to transition from producing clinical supply to building pre-launch inventory of Tyvaso DPI, pending FDA approval. MannKind’s manufacturing and R&D facility in Danbury is scaling up by hiring more than 100 positions, as well as readying essential equipment and production lines. A variety of MannKind jobs in commercial manufacturing, engineering, quality control, warehouse operations, maintenance, and more are currently open and planned to be filled this year.
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Post by mango on Jun 17, 2021 7:25:32 GMT -5
An updated near-term development list
🥭 Tyvaso DPI FDA approval OCTOBER this year
🥭 Afrezza Peds Phase 3 this year
🥭 Clofazimine Phase 1 this year
🥭 Royalties from Thyquidity Co-Promote w/ Vertice Pharma starts NOW
🥭 MannKind and Thirona Bio Join Forces to Develop Inhaled Therapy for Fibrotic Lung Diseases
🥭 BluHale Pro Launch this year
🥭 Afrezza European Union filing this year—NO additional clinical trials required!
🥭 Afrezza filing in Canada
🥭 Afrezza Australia approval this year
🥭 $100M+ in annual royalties from partner $UTHR for Tyvaso DPI
🥭 >$300M in cash—enough to get us to cash flow break even!
🥭 Celebrity Race car deal with Conor Daly
🥭 Cannabis partner Receptor Life Sciences Phase 1 incoming
🥭 Pipeline advancement
🥭 New partnerships
🥭 Afrezza India Clinical Trial this year
🥭 Further Debt Reduction
🥭 New Afrezza scientific publications this year
🥭 Renegotiated w/ Amphastar insulin supply to lower cost of goods
🥭 Numerous new analysts coverage & upgrades
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Post by veritasfiliatemporis on Jun 17, 2021 8:36:56 GMT -5
Carlo selling half shares at 50$  |
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