paul
Researcher
Posts: 134
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Post by paul on Aug 22, 2019 22:59:05 GMT -5
So why Amphastar gave it up seemly for free? Even if they thought there was an opportunity, they might have decided it didn't fit with their overall strategy. In those situations it might have more value to MNKD than to Amphastar (and undoubtedly not a right that Amphastar could sell/transfer to anyone else). Those are good chips to have in negotiation where you can give something up that the other party values, but doesn't have much value to you. I'm presuming that Amphastar, for whatever reason, decided they didn't won't to market in China since they've had a long time to commence something and have chosen not to. But even if they decided it didn't fit with their strategy, why give up the right now? Having the right doesn't affect their strategy. More rational would be at least to hold on to the right to see if something developed such as a China partner for Mannkind wherein the right could become very valuable.
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Post by sayhey24 on Aug 23, 2019 5:44:11 GMT -5
Poor "Skeptic" in the comment section. He seems to have lost his mind. For the last several years Skeptic and Spencer have been tied at the hip. Its great to see things turning.
No questions from Spencer on RLS to me was a big miss as this remains the big mystery with the huge potential. This requires direct questions even if the answer is no comment.
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Post by lifebreath on Aug 23, 2019 6:29:08 GMT -5
Poor "Skeptic" in the comment section. He seems to have lost his mind. For the last several years Skeptic and Spencer have been tied at the hip. Its great to see things turning. No questions from Spencer on RLS to me was a big miss as this remains the big mystery with the huge potential. This requires direct questions even if the answer is no comment. Spencer did not ask about RLS because they are completely irrelevant to MNKD’s near term financial condition which is still uncertain. You should expect more dilution soon.
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Post by sportsrancho on Aug 23, 2019 6:35:44 GMT -5
Poor "Skeptic" in the comment section. He seems to have lost his mind. For the last several years Skeptic and Spencer have been tied at the hip. Its great to see things turning. No questions from Spencer on RLS to me was a big miss as this remains the big mystery with the huge potential. This requires direct questions even if the answer is no comment. Spencer has had him on block now for quite a while and yesterday he spammed that whole comment section! “Thanks for nothing Rising Skeptic by hijacking the comments section with back to back to back to back to back to back to back posts, twice. Spence has you blocked for a reason but he needs to unblock you and have you and your posts removed for incessant FUD pumping.”
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Post by mnholdem on Aug 23, 2019 7:16:18 GMT -5
Positive:
Mike - You had the opportunity to talk with Dr. David Kendall and I think you can see he has been hard at work building out the scientific story among diabetes thought leaders, through clinical presentations at scientific conferences, upcoming publications in peer-reviewed journals and dozens of interactions with physicians across the country every month. As you may have seen, the ADA standards of care were updated in December to reflect the unique attributes of Afrezza, which are a direct result the new data we generated and published. David has been a great addition to the team and is continuing to make strides in shifting the thought process among his peers. Three years ago we were met with skepticism. Now we are met with people wanting to know and see more. With each study conducted, scientific presentation made, and publication published, we are getting closer to delivering a true shift in this space.
Analysis: I believe this to be true. Afrezza is such a change from the status quo (aka disruptor) for diabetes that it will require much more effort to educate the medical community than would, say, another injectable insulin. Peer-reviewed publications in major medical journals are critical and are way behind schedule. To date, there have been no publications about Technosphere Insulin in any major medical publication. Even CMO Kendall mentioned this last year during a conference call. What could be problematic however is that over the past few years, some major publishers in the class of AMA, NEJM and Lancet, have been accused of losing their objectivity due to alleged influence by giant pharmaceutical companies. These publishers have protocols for submitting peer-reviewed papers and there is often a review committee that can and will work with the authors to add/remove material. It can be a lengthy process that still ends up being rejected. Kendall's credentials may come into play here...
Neutral/Negative:
Mike - We are focused on continuing to drive steady trends with about 6,000 active patients on the product and growing each quarter. We believe there is a tipping point, but don’t know if it’s 1000 scripts a week or 5000. My guess is somewhere in that range, doctors will finally be seeing first-hand enough patients getting results that Afrezza will potentially become their go-to tool for mealtime control. It is possible that a tipping point will come when pediatric patients are able to access Afrezza, but we need to conduct more research in this area to understand the opportunity for patients below the age of 18.
Analysis: This "possible tipping point" is at least two years from now and, as noted above, if MannKind is not successful in using the period between now and label expansion to educate pediatricians then they may face as much resistance to prescribing to minors and they have with prescribing to adults. Perhaps the CEO simply didn't choose his words well, but I saw an immediate red flag with his remark "we need to conduct more research in this area to understand the opportunity..." in regard to pediatrics. Really? He doesn't understand the opportunity? It comes across as implying "I don't know". The remark about the tipping point is almost an admission the CEO acknowledges that his current plan for significant adoption in prescribing to adults may not be a success. Again, it may have simply been a poor choice of words, but I felt immediate alarm over the comment.
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Post by longliner on Aug 23, 2019 9:45:31 GMT -5
Poor "Skeptic" in the comment section. He seems to have lost his mind. For the last several years Skeptic and Spencer have been tied at the hip. Its great to see things turning. No questions from Spencer on RLS to me was a big miss as this remains the big mystery with the huge potential. This requires direct questions even if the answer is no comment. Spencer has had him on block now for quite a while and yesterday he spammed that whole comment section! “Thanks for nothing Rising Skeptic by hijacking the comments section with back to back to back to back to back to back to back posts, twice. Spence has you blocked for a reason but he needs to unblock you and have you and your posts removed for incessant FUD pumping.” Did SO blow a "dog whistle to his short friends? Did skeptic get caught on the (short) end of things? Will RLS ever find their way out of the forest? To find out stay tuned as these are the days of our lives.😂
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Post by brianrocco on Aug 23, 2019 11:13:12 GMT -5
Lots of positives with the "fireside chat".
A couple of failures from my perspective: 1) No discussion of the weak label, and how/when to change the label or detour around it. (My opinion of the FDA is deeply marred by their failure to deal with the Oxycontin [spelling?] epidemic.) 2) No discussion of poor insurance coverage, and when it will improve. 3) Most important to me, no explicit recognition of the disasterously weak refill rate. How can a "tipping point" in sales occur before effective usage of Afrezza, as reflected in the refill rate, improves substantially? Mike talked about the top 25 prescribers moving up to 500 prescriptions per quarter. The slow increase in number of refills indicates that even the "new" prescriptions by those doctors sold on Afrezza are not leading to strong refills. (It would be very encouraging if Mike could point to a positive refill rate among the patients of those prescribers.) Does effective dosing depend upon off-label usage? Why does the FDA consider Vdex off-label? I applaud Mannkind's new dosing protocol and working with One-Drop. Will they show a path forward on effective usage of Afrezza and when?
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Post by apidistra on Aug 23, 2019 13:24:08 GMT -5
I've been involved with China in business since the 1980s. That siren song of huge market, tremendous opportunity has been sung for far too long and it is entirely unwarranted.
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Post by sportsrancho on Aug 24, 2019 9:30:23 GMT -5
seekingalpha.com/article/4287690The cash situation at MannKind has improved quite a bit. More specifically, the cash flow situation has improved. Based on what I saw in the Q2 numbers, I have decreased the burn rate by a bit over 15%. These weekly savings will add up and represent $300,000 a week less in spending. These savings are partially offset by slower projected sales, but the infusion of cash and the outlay of lump sums are greatly improved.
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Post by hellodolly on Aug 24, 2019 19:38:22 GMT -5
Poor "Skeptic" in the comment section. He seems to have lost his mind. For the last several years Skeptic and Spencer have been tied at the hip. Its great to see things turning. No questions from Spencer on RLS to me was a big miss as this remains the big mystery with the huge potential. This requires direct questions even if the answer is no comment. Spencer has had him on block now for quite a while and yesterday he spammed that whole comment section! “Thanks for nothing Rising Skeptic by hijacking the comments section with back to back to back to back to back to back to back posts, twice. Spence has you blocked for a reason but he needs to unblock you and have you and your posts removed for incessant FUD pumping.” Rising Sewer is losing his punch. He's getting hit back now and his layers of commingling words are being revealed, like layers on an onion. He doesn't even know what he's saying anymore: RS- "If there WAS a warning letter THIS time around, why hasn't the FDA announced it?" Seeking Alpha Follower: The first references was an announcement by the FDA, with an entirely different set of facts, circumstances and results that didn't necessitate a 'Warning Letter' but rather a 'Letter of Inquiry" (both your words). You have used in your responses the following: 1. Letter 2. Letter of Inquiry, & 3. Warning Letter. What's next? Cease and Desist? You can't make a point so YOU interject and embellish to TRY and make a point. Apparently, sewer went from using benign terms to deeper embellishing terms. LOL. Tool bag.
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Post by sportsrancho on Aug 27, 2019 9:13:42 GMT -5
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Post by dh4mizzou on Aug 27, 2019 9:41:29 GMT -5
Thanks Sports. That was about as middle of the road as one could expect from Mr. Osborne.
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Post by Clement on Aug 27, 2019 10:25:38 GMT -5
Re: Technosphere and tadalafil SO wrote, ".... even potential bad news has a pretty decent silver lining." SO explains that UTHR might choose yes to advance the "secret molecule", but it's equally likely that they will say no. Even if UTHR chooses no, Mannkind will have data and can PR that Mannkind now has a formulation for this "consumer driven" product on the Technosphere platform.
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Post by sportsrancho on Aug 28, 2019 8:07:12 GMT -5
Comment from Spencer....Readers.....
I got a question outside of the comment section which was as follows:
"Why would united pay $10 million if it was not seriously planning on proceeding"
The answer gets a bit complex, and could involve MannKind more than people think.
1. At the time of the deal with United, MannKind was down to less than $10 million in cash. If you recall, there was a contract written for TrepT, and then (almost as if an afterthought) there was a separate contract for this undisclosed molecule. Also recall that the TrepT deal needed an HSR review BEFORE MannKind received $45 million. That means that even with a TrepT deal in hand, MannKind was still desperately low on cash because the $45 million was a month away or more. Perhaps (and this is speculation) the TrepT deal had $55 million up front in the initial discussions. Mannkind NEEDED cash quick. One way around that is to choose a second molecule which did not require HSR review. Perhaps (bear in mind that this is very speculative) they arrived at this solution, which took $10 million away from a TrepT up front payment and applied it to the secret molecule. MannKind gets much needed cash NOW, and United locks up rates on the whole PAH sector.
2. At the time the MannKind deal was announced, United had not yet inked a deal with Arena. Arena's Ralinepag was viewed as the cream of the crop in WHO group 1 treatment. United would be looking to have a back-up plan in case discussions with Arena broke down, or United got outbid for Ralinepag. A dry powder Adcirca could be a stop gap defense (albeit a weak one). Spending $10 million to have a back-up plan on a Ralinepag deal that was going to be $1 billion is cheap insurance.
3. At the time United was seeing quarterly sales that were about to come in at $42 million on Adcirca. United had no way to know what level of impact generics would have at that point. As it turns out, generics have decimated the sales of Adcirca. The new data means a new decision point.
4. United could use a new Adcirca formulation to entice Lilly into better terms after December 31, 2020.
5. United was going to face the ire of shareholders on the impact of generics. The company had stated that it has a good handle on retaining people on the branded meds, but with Adcirca (being as high profile as it is) that might prove difficult. Having a new potential formulation to talk about could be money well spent.
At any rate, you can see the complexities as to why. None of these may be right, and all of them could be.
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