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Post by mnkdfann on Oct 19, 2021 12:01:02 GMT -5
Two months ago tomorrow (August 19th) MNKD closed at $3.97. Today it closed at $4.16. Six months ago MNKD closed at 4.16. Yesterday 4.16. During that six months the price ranged from 3.61 to 5.40. So, MNKD was pretty much dead money for the past six months unless one was actively trading, buying and selling. I'm no genius, but fortunately I did sell a third of my MNKD shares around the 5.20 range. Even more fortunately, my MNKD holdings are a minuscule portion of my overall portfolio, and most of the rest (like oil, gas, crypto, financials) are doing much better. |
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FDA delay
Oct 19, 2021 13:54:37 GMT -5
via mobile
Post by cretin11 on Oct 19, 2021 13:54:37 GMT -5
I appreciate the well reasoned responses to my question, with snarky comments kept mostly in check. We all seem to agree that dilution should not be needed this time (or ever again?), though it is a topic which many of us indeed have considered and are wise to consider until we become profitable. Keep dancing with dilution Cretin. Spread your dilution dust..... make sure we have to pick it out of our noses every day, so we do not forget to pick our noses. Fantastic imagery, well done peppy! 😄❤️🤧 |
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Post by peppy on Oct 19, 2021 13:56:00 GMT -5
Keep dancing with dilution Cretin. Spread your dilution dust..... make sure we have to pick it out of our noses every day, so we do not forget to pick our noses. Fantastic imagery, well done peppy! 😄❤️🤧 I know. Now I have to wash my hands. |
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Post by bthomas55ep on Oct 20, 2021 5:58:14 GMT -5
Just wondering out loud. Does an FDA six month clock review happen from the date of the CRL, or does UTHR have to correct the issues at the testing facility, submit an updated NDA to request review, and wait for the FDA to accept the new application before the clock re-starts? Anyone with experience in this area know?
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Post by prcgorman2 on Oct 20, 2021 6:43:31 GMT -5
Good question. I hope you get a good answer. I’d assumed the reference to “approved” in “summer” of 22 was based on a 1 year (ish?) clock for drug approvals. The expedited review was completed but I don’t think the un-expedited clock stopped.
Expedited reviews came about because the FDA was too slow so Congress passed a law to get FDA to be more responsive and to provide for expedites but making the pharmas that want those pay for them.
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Post by boca1girl on Oct 20, 2021 8:43:08 GMT -5
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Post by celo on Oct 20, 2021 9:14:19 GMT -5
7 month delay for an inspection issue at a QA/QC firm after you pay 100 million for an expedited review. Just plain lame.
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Post by sr71 on Oct 20, 2021 10:27:49 GMT -5
I'm not an attorney, but I would think that UTHR (and MNKD) should have excellent grounds for a lawsuit against the lab. I can't imagine that the contract for lab services would not have a provision that the lab would abide by all FDA requirements. Besides loss of near-term revenue from sales, Martine is out $100 million for the PRV, and Mannkind's near-term revenues from manufacturing and royalties are likely damaged as well. I wonder what the lab's policy limit is for liability coverage?
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Post by mcbone on Oct 20, 2021 10:28:29 GMT -5
Just wondering out loud. Does an FDA six month clock review happen from the date of the CRL, or does UTHR have to correct the issues at the testing facility, submit an updated NDA to request review, and wait for the FDA to accept the new application before the clock re-starts? Anyone with experience in this area know? I discussed this earlier in this thread: "Looks like the resubmission will be a "Class 2," meaning that the FDA gets 6 months to review after UTHR resubmits the app with the defect corrected. See www.fda.gov/media/72727/download. "
I would imagine that UTHR is sparing no expense to get the testing issue remedied and the app resubmitted as quickly as possible.
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Post by mcbone on Oct 20, 2021 10:31:38 GMT -5
I'm not an attorney, but I would think that UTHR (and MNKD) should have excellent grounds for a lawsuit against the lab. I can't imagine that the contract for lab services would not have a provision that the lab would abide by all FDA requirements. Besides loss of near-term revenue from sales, Martine is out $100 million for the PRV, and Mannkind's near-term revenues from manufacturing and royalties are likely damaged as well. I wonder what the lab's policy limit is for liability coverage? Well, they're still a couple months ahead of where they would have been, assuming a non-expedited review would have produced the same CRL with the testing problem. |
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Post by prcgorman2 on Oct 21, 2021 7:06:21 GMT -5
I'm not an attorney, but I would think that UTHR (and MNKD) should have excellent grounds for a lawsuit against the lab. I can't imagine that the contract for lab services would not have a provision that the lab would abide by all FDA requirements. Besides loss of near-term revenue from sales, Martine is out $100 million for the PRV, and Mannkind's near-term revenues from manufacturing and royalties are likely damaged as well. I wonder what the lab's policy limit is for liability coverage? Well, they're still a couple months ahead of where they would have been, assuming a non-expedited review would have produced the same CRL with the testing problem. I can’t argue with your reasoning but to mix metaphors it still feels a little like lipstick on a pig more than a silver lining. |
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Post by Clement on Oct 21, 2021 7:59:03 GMT -5
Due to this delay in approval of Tyvaso-DPI, MNKD will not see royalty revenues until summer of 2022 or earlier.
But for UTHR it's different. During this time UTHR will be rapidly adding PHILD* patients on Tyvaso-nebulizer. UTHR will maintain its number pf PAH patients. UTHR revenues will increase dramatically.
Back to MNKD. When approval finally happens, there will be both PHILD patients as well as PAH patients ready and waiting to convert to Tyvaso-DPI. I think the amended Supply Agreement is UTHR's effort to make sure there is enough product when this happens. MNKD's royalty revenues will be bigger, faster than if approval happened this month. I hope analysts can see this coming.
*UTHR had beefed up its pulmonary hypertension sales force by 40% and had educated them before PHILD (Tyvaso-nebulizer) approval in April.
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Post by cedafuntennis on Oct 21, 2021 8:30:59 GMT -5
Due to this delay in approval of Tyvaso-DPI, MNKD will not see royalty revenues until summer of 2022 or earlier. But for UTHR it's different. During this time UTHR will be rapidly adding PHILD* patients on Tyvaso-nebulizer. UTHR will maintain its number pf PAH patients. UTHR revenues will increase dramatically. Back to MNKD. When approval finally happens, there will be both PHILD patients as well as PAH patients ready and waiting to convert to Tyvaso-DPI. I think the amended Supply Agreement is UTHR's effort to make sure there is enough product when this happens. MNKD's royalty revenues will be bigger, faster than if approval happened this month. I hope analysts can see this coming.*In the meantime MNKD will receive its manufacturing 'cost plus' share from UTHR at least, if not also the money slayed for the QA completion. That's many millions shortly. |
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FDA delay
Oct 21, 2021 10:23:57 GMT -5
via mobile
Post by wkndplyr on Oct 21, 2021 10:23:57 GMT -5
I doubt any future companies will be giving money to the fda for early approval.
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Post by goyocafe on Oct 21, 2021 10:28:49 GMT -5
I doubt any future companies will be giving money to the fda for early approval. The FDA didn't get any money for the expedited review. They dole out the vouchers for new drugs with perceived urgency. What the biotech co does with it is their business. Sometimes they sell them to other companies for big money. The FDA honors them, but I'm sure they feel that it's a misused system in cases where the review is not for the original purpose for which they issued it. |
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