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Post by mnkdfann on Feb 9, 2022 20:45:29 GMT -5
Just curious. Wikipedia lists 2 subsidiaries for Mannkind Inc. "Subsidiaries: Qrumpharma, Inc., MannKind LLC". What is Mannkind LLC? Seems to be managed by Jessica Mann (Al's daughter?) and is based in NV. I don't see anything on this wikipedia page about any Mannkind LLC: en.wikipedia.org/wiki/MannKind_Corporation Anyway, I think any reference to Mannkind LLC is to what mytakeonit said. This company: mannkindhorizons.com/
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Post by mnkdfann on Feb 9, 2022 20:36:10 GMT -5
MannKind has registered a booth in pretty good position across from Dexcom. I don't think MannKind has had a booth at one of these conferences in quite awhile. Actually, and this is from a quick search online, it appears Mannkind did have a booth there in 2018 and 2019. The conference was online last year, and it hosted a virtual booth then. But, in 2020, Mannkind did skip the booth - MC said it was costing too much and wasn't worth it (or something to that effect).
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Post by mnkdfann on Feb 9, 2022 18:30:56 GMT -5
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Post by mnkdfann on Nov 5, 2021 17:54:33 GMT -5
Mike sold his shares in Mannkind when SNY became our partner. I’ll bet he he’s spending his money on something else in today’s market. JMHO If it is obvious why he sold his MNKD shares at that time, I don't see it. Any idea why he sold them then? To buy SNY shares?
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Post by mnkdfann on Nov 4, 2021 15:28:16 GMT -5
P/E ratio LLY 41 MRK 31 JNJ 24 NVO 38 BIIB 27 You screened for P/E >= 24? Of course then you will find some. But they are the exceptions, and the overall average for Pharma is much less. PFE 15.6 TEVA 3.7 UTHR 15.8 Also, it makes a difference if you are looking at TTM or Forward looking P/Es. For example, BIIB certainly is 27, looking back. Current expectations going forward are 15.6.
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Post by mnkdfann on Nov 4, 2021 14:47:01 GMT -5
Now we have to speculate on what the appropriate P/E (price/earnings) multiple will be. With the average P/E for all U.S. stocks ranging from 20 to 25, I’ll posit a P/E of 25, which, therefore, suggests that MNKD’s stock price will be $15.75. at year-end 2022. Obviously, one can disagree with any of the assumptions, but I offer the foregoing analysis as a basis for a reasoned dialogue. Overall not a bad analysis, but ... A few months ago, an article in Forbes noted: "Major pharmaceutical companies trade for an average of 13 times projected 2021 earnings, against a price/earnings ratio of 22 for the S&P" I'm not certain what the situation is today, but I have doubts that a P/E of 25 is realistic (once MNKD starts turning a profit and settles down). I suspect it would be quite a bit less. E.g., UTHR's is only about 13 (according to one finance site).
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Post by mnkdfann on Nov 3, 2021 20:14:43 GMT -5
Did anyone else notice that one of the authors is a consultant to Mannkind?
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Post by mnkdfann on Oct 21, 2021 12:20:45 GMT -5
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. goyocafe I could not agree more. It is accurate that FDA does not sell expedited review vouchers. I'm not sure who dreamed up the voucher system but it does not serve the interest of the public to have expedited reviews given for one reason and used for another while at the same time creating a back market for using the vouchers as currency. For an agency that has answered to Congress for its long review times, especially for life-saving drugs, this seems counterproductive. And clearly, the public does not understand it either. How are these valued in the eyes of analysts? If MNKD held a voucher, for example, could they claim it had value on their balance sheet knowing it could be sold for $100M? IMO, It should be a "use it or lose it within a specified timeframe for the purposes granted" type of policy. Period. Full stop. After all, where does public interest and public health come into play? Think mission, FDA lads and lasses, think mission, because the mission is why you exist and why our tax dollars fund your operations. JMHO Chris I thought the expedited review vouchers were given to companies to spur investigation and development of needed drugs. What a company ultimately did with the voucher was left to the company, but either way the desired needed drug was put into development. There are a lot of subtleties to the program, but the original intent was always to allow companies to sell the vouchers if that helped them more. Note, originally a company even had to announce its intention to use a priority review voucher 365 days in advance, i.e. before they had even run trials to know if the drug was successful or not. I'm not arguing for or against anything, just pointing out there are a lot of subtleties and I think it all rather complex. This seems a reasonable 'summary' ... www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers
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Post by mnkdfann on Oct 20, 2021 19:04:51 GMT -5
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Post by mnkdfann on Oct 20, 2021 14:13:22 GMT -5
Montgomery's team theorized that knocking out the pig gene for a carbohydrate that triggers rejection - a sugar molecule, or glycan, called alpha-gal - would prevent the problem. The genetically altered pig, dubbed GalSafe, was developed by United Therapeutics Corp's Revivicor unit. Revivicor? Sounds ominous. Reminds me of what is described in RoboCop and Universal Soldier, and like movies.
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Post by mnkdfann on Oct 20, 2021 14:08:13 GMT -5
Words cannot express how happy I am that we can continue this discussion and CRL speculations until Summer 2022.
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Post by mnkdfann on Oct 19, 2021 12:49:56 GMT -5
Dumb this down for me. Is there a problem with the compound, Treprostinil? Or is there a problem at the lab testing the Treprostinil? MNKD is getting its Treprostinil from UTHR correct? Who get it from Sandoz, a division of Novartis. The FDA's letter noted only a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.In a nutshell..the test lab got hit The fix is simply to change to another lab and test lots. Have FDA look at new lab..done (prefer a dedicated lab with no out of production clients) The problem is that simple often isn't easy. "Simple means something basic and not complicated. Easy means not difficult."
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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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Post by mnkdfann on Oct 18, 2021 18:04:47 GMT -5
FWIW, we should all keep in mind we are only getting a biased part of the story from UTHR (biased in the sense that UTHR is only telling us what it wants us to hear, and may be leaving parts out or phrasing things in an overly optimistically manner). www.agencyiq.com/the-fdas-complete-response-letter-secrecy-could-be-on-a-crash-course-with-covid/A study of CRLs published in the British Medical Journal compared the full CRLs with press releases by the companies to which the CRLs were issued (the authors, who were FDA staffers, had access to both). The study concluded:
“FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters.
Press releases are incomplete substitutes for the detailed information contained in complete response letters.”
These findings suggest that companies are cherry-picking what to disclose when the FDA doesn’t approve a drug or biologic outright.
Even with high profile drugs that have demonstrated safety and efficacy and are likely to ultimately gain approval, drugmakers can downplay or remain opaque about the contours of the CRL.
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Post by mnkdfann on Oct 12, 2021 7:30:16 GMT -5
While I am as long as most on this board, I have noticed there hasn't been any talk about the albeit very small chance of TrepT not getting approval. There was a week or two ago in the Tyvaso thread. I brought up the idea of entering into an options straddle.
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