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Post by hellodolly on Dec 17, 2022 8:28:42 GMT -5
Could this be the reason for the sudden jump in SP? This was posted in another thread here and I don't think many saw it. 12/14/2022: The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher. Source: www.federalregister.gov/documents/2022/12/14/2022-27138/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucherCurious about this in the Federal Register Announcement: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher "Notice of Approval" for what? The voucher or for the drug for pediatrics? |
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Post by sayhey24 on Dec 17, 2022 8:46:11 GMT -5
Dolly - they were given the thumbs up by the FDA to use the voucher for a "forthcoming New Drug Application" for Tyvaso DPI which will be used for a Rare Pediatric Disease. What the time line is for "forthcoming" IDK.
This could be the reason for the recent pps rise but I have a feeling we have a new interested party with their eye on MNKD. Just a feeling with no solid evidence.
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Post by Clement on Dec 17, 2022 8:50:00 GMT -5
At Tyvaso.com, you can access a pdf (Revised: 05/2022) entitled "TYVASO DPI Prescribing Information". On page 7, it says, "8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Clinical studies of inhaled treprostinil did not include patients younger than 18 years to determine whether they respond differently from older patients." www.tyvaso.com/pdf/TYVASO-DPI-PI.pdf |
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Post by hellodolly on Dec 17, 2022 9:00:25 GMT -5
At Tyvaso.com, you can access a pdf (Revised: 05/2022) entitled "TYVASO DPI Prescribing Information". On page 7, it says, "8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Clinical studies of inhaled treprostinil did not include patients younger than 18 years to determine whether they respond differently from older patients." www.tyvaso.com/pdf/TYVASO-DPI-PI.pdfThanks Clem. So, they got a PRV. I think they will use it for Tyvaso, DPI for children after a study. |
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Post by oldfishtowner on Dec 17, 2022 10:00:45 GMT -5
See harryx1's original post on the subject under the DPI News thread. I think his edit remark is correct that this is a post facto notice concerning approval of UTHR's use of the voucher for priority approval of Tyvaso DPI and not the issuance of a new voucher.
The title of the notice clearly states that this is regarding "approval of product under voucher" and not the issuance of a new voucher. The last sentence of the notice says, "FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher." [my bolds]
Likely a formality that the FDA didn't get around to earlier.
If it was the reason for the bounce in the PPS, expect a reversal soon. If not, then there is some other reason as sayhey suggests.
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Post by Thundersnow on Dec 17, 2022 11:12:56 GMT -5
Dolly - they were given the thumbs up by the FDA to use the voucher for a "forthcoming New Drug Application" for Tyvaso DPI which will be used for a Rare Pediatric Disease. What the time line is for "forthcoming" IDK. This could be the reason for the recent pps rise but I have a feeling we have a new interested party with their eye on MNKD. Just a feeling with no solid evidence. Don't forget Clofazimine is coming out of Phase 1 which could bring a new Partner and 501 is completing P1. I think the market is waking up to the fact that MNKD & DPI Revenues will blow the doors off this quarter. It could jump 4-5x last Qtr. Thats is huge! Good times are coming! |
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Post by lennymnkd on Dec 17, 2022 12:16:38 GMT -5
Not to mention the secret molecule
Mike has in his desk at work.. not disclosed for competitive
Reasons .
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Post by hellodolly on Dec 17, 2022 14:50:03 GMT -5
Dolly - they were given the thumbs up by the FDA to use the voucher for a "forthcoming New Drug Application" for Tyvaso DPI which will be used for a Rare Pediatric Disease. What the time line is for "forthcoming" IDK. This could be the reason for the recent pps rise but I have a feeling we have a new interested party with their eye on MNKD. Just a feeling with no solid evidence. I think that's more the case than the FDA thumbs up. The volume for the last few weeks has been closing above their 10D avg. I looked back and out of the last 36 trading sessions, 22 were above average volume days, nearly 66% of the sessions. Many of those had large volumes flowing during the last 30 minutes of the trading session. One of the threads on PB, I made a comment that I've been watching this pattern and thought it was quiet accumulation. |
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Post by prcgorman2 on Dec 17, 2022 15:07:02 GMT -5
Dolly - they were given the thumbs up by the FDA to use the voucher for a "forthcoming New Drug Application" for Tyvaso DPI which will be used for a Rare Pediatric Disease. What the time line is for "forthcoming" IDK. This could be the reason for the recent pps rise but I have a feeling we have a new interested party with their eye on MNKD. Just a feeling with no solid evidence. I think that's more the case than the FDA thumbs up. The volume for the last few weeks has been closing above their 10D avg. I looked back and out of the last 36 trading sessions, 22 were above average volume days, nearly 66% of the sessions. Many of those had large volumes flowing during the last 30 minutes of the trading session. One of the threads on PB, I made a comment that I've been watching this pattern and thought it was quiet accumulation. I've noticed the "power hour" purchasing too. Agree with "quiet accumulation". Greater than 5% ownership of voting shares require a disclosure to the SEC, so if it's serious, sooner or later it will be made public. |
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Post by hellodolly on Dec 17, 2022 15:49:06 GMT -5
I think that's more the case than the FDA thumbs up. The volume for the last few weeks has been closing above their 10D avg. I looked back and out of the last 36 trading sessions, 22 were above average volume days, nearly 66% of the sessions. Many of those had large volumes flowing during the last 30 minutes of the trading session. One of the threads on PB, I made a comment that I've been watching this pattern and thought it was quiet accumulation. I've noticed the "power hour" purchasing too. Agree with "quiet accumulation". Greater than 5% ownership of voting shares require a disclosure to the SEC, so if it's serious, sooner or later it will be made public. Yes, remind me. 45 days to post the 13Fs after the quarter closes? So, mid Feb for these Q4 purchases or, 5% and immediate filing required? |
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Post by prcgorman2 on Dec 17, 2022 15:55:39 GMT -5
I've noticed the "power hour" purchasing too. Agree with "quiet accumulation". Greater than 5% ownership of voting shares require a disclosure to the SEC, so if it's serious, sooner or later it will be made public. Yes, remind me. 45 days to post the 13Fs after the quarter closes? So, mid Feb for these Q4 purchases or, 5% and immediate filing required? |
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Post by agedhippie on Dec 17, 2022 16:46:49 GMT -5
If you think Tyvaso DPI has good prospects, but you don't want all the legacy versions and drugs then MNKD makes a good proxy for UTHR in that area.
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Post by prcgorman2 on Dec 17, 2022 18:15:36 GMT -5
If you think Tyvaso DPI has good prospects, but you don't want all the legacy versions and drugs then MNKD makes a good proxy for UTHR in that area. Oof. That's saying horrible things for Afrezza. Like "shelved and forgotten". |
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Post by agedhippie on Dec 17, 2022 18:47:36 GMT -5
If you think Tyvaso DPI has good prospects, but you don't want all the legacy versions and drugs then MNKD makes a good proxy for UTHR in that area. Oof. That's saying horrible things for Afrezza. Like "shelved and forgotten". I think if you were taking that particular bet you would be have to be expecting DPI to contribute considerably more to the bottom line. Afrezza would be viewed as a wash (breakeven) so it could be ignored. |
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Post by prcgorman2 on Dec 17, 2022 19:07:32 GMT -5
Oof. That's saying horrible things for Afrezza. Like "shelved and forgotten". I think if you were taking that particular bet you would be have to be expecting DPI to contribute considerably more to the bottom line. Afrezza would be viewed as a wash (breakeven) so it could be ignored. Not necessarily. It could also happen that one of the big 3 could recognize chances were better than even that Mannkind and Afrezza aren't going away and now is the last chance to acquire them at a less than egregious cost. I would expect an offer to be 2x to 3x current share price. I suspect that might be sufficient to ensure approval by the board and shareholders. I assume it would be the end for Afrezza. That bothers me. Especially since I may become a Type 2 diabetic and I've been counting on being able to use a CGM and Afrezza to manage my diabetes.
But, I may have too great of a bias about Mannkind. 2x or 3x is a lot of money and the competitors may just (continue to) be unconcerned about Afrezza, so no reason to do anything in that regard. In that case, your view would be correct. |
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