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Post by mango on Oct 18, 2021 12:39:39 GMT -5
This position we have found ourselves in definitely sucks, but what do we do? We work hard by utilizing our skills to put ourselves back into an advantageous position. MannKind will be fine, we know what to do.
Clofazimine Phase 1 this quarter.
The label is a huge positive:
No Black Box
No contraindications
Includes both indications PAH, PH-ILD
I am not worried about the Citizen Petition.
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Post by lazyb767 on Oct 18, 2021 12:50:25 GMT -5
This position we have found ourselves in definitely sucks, but what do we do? We work hard by utilizing our skills to put ourselves back into an advantageous position. MannKind will be fine, we know what to do. Clofazimine Phase 1 this quarter. The label is a huge positive: No Black Box No contraindications Includes both indications PAH, PH-ILD I am not worried about the Citizen Petition. So... Not a SP liability, but again, a buying opportunity? Still trying to sort this out, might be working myself into an "intervention" opportunity.  Buy 500 Shares of MNKD at Market (Day) Filled at $4.1068 Buy 500 Shares of MNKD at Market (Day) Filled at $4.203 Buy 500 Shares of MNKD at Market (Day) Filled at $4.2987 in inverse order. Workin' hard to get my fill Everybody wants a thrill Payin' anything to roll the dice Just one more time Some will win Some will lose Some were born to sing the blues... "If you don't dig the Blues you got a hole in your soul." ~ Albert King |
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Post by awesomo on Oct 18, 2021 12:50:58 GMT -5
This position we have found ourselves in definitely sucks, but what do we do? We work hard by utilizing our skills to put ourselves back into an advantageous position. MannKind will be fine, we know what to do. Clofazimine Phase 1 this quarter. The label is a huge positive: No Black Box No contraindications Includes both indications PAH, PH-ILD I am not worried about the Citizen Petition. You can't claim how great the label is with a CRL. The label is not definitive at this point whatsoever. You may not be worried about the Citizen Petition, but it is still very much in play. |
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Post by cretin11 on Oct 18, 2021 13:12:56 GMT -5
Not sure where to put this and didn’t want to start a new thread, but obviously many of us are thinking about the potential now for dilution.
When the leaseback deal got done, did certain folks have an inkling this CRL was coming?
Also, we remember the MNKD executives’ bonus “formula” from past years. In order to make that formula spit out a favorable number, one of the metrics was (still is presumably?) getting the balance sheet looking better. What are the odds of another Xmas massacre or something of that nature?
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Post by phantomfj on Oct 18, 2021 13:37:57 GMT -5
Not sure where to put this and didn’t want to start a new thread, but obviously many of us are thinking about the potential now for dilution. When the leaseback deal got done, did certain folks have an inkling this CRL was coming? Also, we remember the MNKD executives’ bonus “formula” from past years. In order to make that formula spit out a favorable number, one of the metrics was (still is presumably?) getting the balance sheet looking better. What are the odds of another Xmas massacre or something of that nature? wow, spread FUD much? How long have you been waiting to drop this "gem"? |
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Post by BD on Oct 18, 2021 13:42:09 GMT -5
Days like this will trigger our own inner FUD, not an unexpected consequence.
Anyway, sorry for buying those 1000 shares on Friday. The day before the next FDA announcement is expected, I'll sell them back so we all get the announcement we actually want...
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Post by mcbone on Oct 18, 2021 13:47:52 GMT -5
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. |
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FDA delay
Oct 18, 2021 14:09:58 GMT -5
via mobile
Post by cretin11 on Oct 18, 2021 14:09:58 GMT -5
Not sure where to put this and didn’t want to start a new thread, but obviously many of us are thinking about the potential now for dilution. When the leaseback deal got done, did certain folks have an inkling this CRL was coming? Also, we remember the MNKD executives’ bonus “formula” from past years. In order to make that formula spit out a favorable number, one of the metrics was (still is presumably?) getting the balance sheet looking better. What are the odds of another Xmas massacre or something of that nature? wow, spread FUD much? How long have you been waiting to drop this "gem"? Really, so that’s your answer. Waiting to drop that “gem”? How about waiting a couple of hours, aka since the news broke today. Or do you think that’s FUD too? There would be no need for dilution if we knew revenues were imminent from Tyvaso. I hope dilution is an impossibility, but would rather see that presented logically instead of the lame (but predictable) baseless FUD accusation. |
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Post by Thundersnow on Oct 18, 2021 14:29:15 GMT -5
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 believe the PRV still in effect? That's why Martine said the deficiency will be corrected in 6 months or EARLIER. |
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Post by sayhey24 on Oct 18, 2021 14:36:02 GMT -5
I am not expecting dilution. I thought Mike put the company in a very strong position. Was he expecting this, maybe so based on questions during the review. Additionally, MNKD is making Tyvaso right now. If so, MNKD is making money. Maybe no royalties but some to cover factory costs.
“We continue to build pre-launch inventory of Tyvaso DPI and look forward to supporting United Therapeutics’ efforts in securing approval of Tyvaso DPI in the coming months,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation.
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Post by markado on Oct 18, 2021 14:47:38 GMT -5
This position we have found ourselves in definitely sucks, but what do we do? We work hard by utilizing our skills to put ourselves back into an advantageous position. MannKind will be fine, we know what to do. Clofazimine Phase 1 this quarter. The label is a huge positive: No Black Box No contraindications Includes both indications PAH, PH-ILD I am not worried about the Citizen Petition. So... Not a SP liability, but again, a buying opportunity? Still trying to sort this out, might be working myself into an "intervention" opportunity. Buy 500 Shares of MNKD at Market (Day) Filled at $4.1068 Buy 500 Shares of MNKD at Market (Day) Filled at $4.203 Buy 500 Shares of MNKD at Market (Day) Filled at $4.2987 in inverse order. Workin' hard to get my fill Everybody wants a thrill Payin' anything to roll the dice Just one more time Some will win Some will lose Some were born to sing the blues..." It goes on and on and on and on.... Sorry - couldn't resist. Humor is my natural stress defense mechanism...Cheers Longs! |
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Post by mcbone on Oct 18, 2021 14:49:42 GMT -5
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 believe the PRV still in effect? That's why Martine said the deficiency will be corrected in 6 months or EARLIER. Not sure if the PRV still applies. But I think that a team of lawyers worked on the press release over the weekend and they chose their words carefully: "Tyvaso DPI can receive approval by the summer of 2022, if not earlier." Hmmm, "by summer"? Is that the beginning of summer, middle or end. Gosh, they just don't say. I am left with the impression that if it gets approved by the end of summer, the quoted prediction is accurate. That's over 11 months away. But one could also be left with the impression that approval would be by June 21, 2022, the beginning of summer. Stating "or earlier" gives the reader some comfort but does not change the fact that the outside of the window is next September. It's all spin. |
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Post by lazyb767 on Oct 18, 2021 14:55:49 GMT -5
www.sec.gov/Archives/edgar/data/1082554/000095013304003382/w01399sv3.htmEarlier SEC Form S-3 (2004 +/- ?) - United Therapeutics relies on Cardinal Health to test the purity of each batch of Remodulin and other products that United Therapeutics is developing. Prior to Cardinal Health acquisition known as Magellan Laboratories Incorporated. Not sure of the accuracy, recency, of this info. YMMV
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Post by ktim on Oct 18, 2021 14:56:07 GMT -5
Someone here speculated that the type of resubmission likely to be used would allow 6 month FDA review, which would imply that early summer would be feasible as long as correcting the problem and resubmitting doesn't take longer than EOY.
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Post by hellodolly on Oct 18, 2021 16:25:46 GMT -5
Someone here speculated that the type of resubmission likely to be used would allow 6 month FDA review, which would imply that early summer would be feasible as long as correcting the problem and resubmitting doesn't take longer than EOY. Have I added correct, we have about $352M after the sale-leaseback and a burn rate averaging the three last quarters of $30M (or avg of $10M a month) giving MNKD about 30 months? |
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