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Post by mnholdem on Dec 31, 2019 17:09:10 GMT -5
Shawn, your comments have, IMO, been a positive contribution to this forum in 2019 an have raised awareness in several areas. Here’s hoping (as I raise my glass) that your $.02 will grow to $.03 during the new year.
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Post by mnholdem on Dec 31, 2019 15:18:23 GMT -5
I thought the speed of action was the greatest benefit of TS delivery. If so, then products like Epi, and migraine relief would be attractive partnering candidates along with pulmonary disease drugs. These new TS products should be far more attractive than the generics. I read that subcutaneous sumitriptan for migraine works in 6 minutes while the nasal spray works in about 15 minutes. Could a TS version compete with those numbers? While I've heard Alfred Mann state that a Sumitriptan-TS could work that fast, I've not read anything close to that speed with injectable/oral triptan-class pain medications. The fastest triptan currently on the market is Imitrex injectable (Glaxo-Smith-Klein also sells Imitrex in nasal spray and pill forms). Imitrex injectable is the only ultra-fast acting triptan and has a 70% response rate. The fast acting triptans are the traditional triptans: Imitrex tablet and nasal spray, Maxalt, Zomig, and Axert. The slow acting/long lasting triptans are Amerge and Frova. We now have a wide range of treatment options for the many presentations of migraine. Imitrex injectable is for the migraine that needs to be stopped as quickly and completely as possible.There is certainly no doubt that the subcutaneous form of Imitrex is the triptan that works the quickest and is most generally effective. It has a 70% efficacy at a one hour response rate compared to a two-hour response rate for all the others.
Source: www.practicalpainmanagement.com/pain/headache/migraine/choosing-right-triptanIncidentally, Imitrex was the #1 migraine drug in 2017 (the last time I checked). Treating migraines in less than one hour remains a huge unmet need, one that Technosphere could capitalize upon, IMO. Incidentally, Imitrex does have the most side effects (see Table 3 in the linked report) but I believe that's in its pill. |
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Post by mnholdem on Dec 31, 2019 6:07:35 GMT -5
The problem with already approved drugs is not failure in the clinical sense, but hurdles in the economic sense. Every drug MNKD has put on their pipeline slide is off-patent, which means there are hungry generics trying to gobble up their share of the market, and getting a third party to fund the new formulation and to pay MNKD a decent royalty (based off already low generic prices) makes it a tough sell to the partner. No question that using approved drugs shortcut the efficacy and some of the safety hurdles, but the economics become the primary concern. Most drugs that do not advance to Phase III fail on the economics, not on safety or efficacy. “ Every drug MNKD has put on their pipeline slide is off-patent, which means there are hungry generics trying to gobble up their share of the market, and getting a third party to fund the new formulation and to pay MNKD a decent royalty (based off already low generic prices) makes it a tough sell to the partner.“ Begs the question then - why would they employ that strategy for every pipeline drug if they are all generic and it’s so difficult to partner? Many of these API were not yet generic when MannKind began investigating them as candidates for use with Technosphere. Even though the current CEO recently emphasized that preclininicals and Phase 1 trials are inexpensive, these drug candidates have been sitting on the proverbial shelf in R&D for years while management made little progress to advance them. It's important to remember that MannKind's pulmonary delivery technologies offers some important advancements that address unmet needs, such as speed and avoidance of certain side effects / efficacy issues often associated with oral medication. Unfortunately, much of the effort which Alfred Mann invested into marketing the company and its technology has been set aside. CMO Kendall (to his credit) mentioned this after he was hired. Matt makes some good comments about generic API, economics and partnerships. I believe that Alfred Mann's style typically was to create technology companies to develop the technologies and sell them. With MannKind, IMO, too few API have been advanced sufficiently for the company's revolutionary technology to appeal much to large pharmaceutical interests. So far, management has demonstrated and marketed more about the company's struggles than its victories. |
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Post by mnholdem on Dec 30, 2019 8:04:38 GMT -5
".. .also I had posted something on another thread here about some have not learned to stop feeding the trolls, evidently that was pulled for whatever reason? Conflict of interest perhaps? I'm curious as to which moderator here pulled that post?" - joeypotsandpansI remember you posting many of your replies that had been filtered/blocked from appearing in the SeekingAlpha response sections, joey, but I cannot say with any certainty which moderator/administrator removed some of your posts. However, please be aware that it sometimes happens that entire groups of posts can get pulled of the main forum whenever thread posts start degrading into character attacks between ProBoard members. While sometimes good posts get tossed with the rest, all members should try to understand that these actions don't signal that moderators are taking anybody's side. The actions are usually only taken when arguments are getting out of hand.  |
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Post by mnholdem on Dec 30, 2019 5:52:46 GMT -5
Could you please include link?
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Post by mnholdem on Dec 24, 2019 12:53:32 GMT -5
MannKind amended the press release. The deadline for CVI to exercise the 4,500,000 warrants is now December 26 at 5pm EST.
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Post by mnholdem on Dec 23, 2019 21:05:23 GMT -5
When are you people going to realize Mike C is working for the shorts? Once again this guy trolls investors for Christmas. We need to oust him and get Bill and Mnholdem on the board. Heck, how about getting me a seat as well? I can be the appointed heckler. Shareholders don’t need hecklers. They need transparency from this company. That will be my primary objective if I’m elected to the board. |
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Post by mnholdem on Dec 23, 2019 11:39:05 GMT -5
Spencer Osborne on stocktwits seems to suggest they did it to raise the 5 million needed to pay Deerfield its milestone payment on 50 million revenues. Is that a fair assessment? It better be to pay DF, the timing and price just make it look like they’re trying to kill the 2019 calls again. Shit, no way I would’ve done this before OPEX, I would’ve given DF an IOU. Those calls are as good as gone, right?. The premiums on those Jan-2020 Call Options are tanking this morning so, basically, it seems that yes is your answer. |
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Post by mnholdem on Dec 23, 2019 7:34:15 GMT -5
I really do not understand this CEO and CFO team. Typically, a company issuing warrants will raise its image because it will reflect the confidence of investor(s) in the company, who agree to purchase shares of the company at a price that is higher than the current market price. It has baffled me why MannKind CEO Michael Castagna offers these sweetheart deals, issuing warrants that are lower that the market share price.
In my opinion, this amendment is NOT in the interests of shareholders and the CEO's action will depress the market price for MNKD shares and erode shareholder value and may even constitute a breach of fiduciary duty to shareholders.
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Post by mnholdem on Dec 23, 2019 7:24:09 GMT -5
CVI must purchase the 4.5M shares of common stock by 9:30am EST today for the remainder of their $1.60 warrant to be extended to a June 2020 termination date....at which date there is no guarantee that this management team may make another sweetheart deal.
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Post by mnholdem on Dec 22, 2019 14:11:13 GMT -5
Not only in the trials!! after Afrezza was launched by Sanofi the label was telling them to take it too early. A guy I worked with would take it 10 to 20 minutes before he would eat, then was afraid to take the follow up dose. I tried to tell him he was taking it too soon, and that he could just take more if he was still out of range, but he said it doesn’t work that way. They, (Sanofi), were just turning patients loose with no direction whatsoever. Because of the label instructing him wrong, the dreamboat caking up, and the cough, we lost him as a patient. Hard to Imagine a Company smart enough to get Afrezza approved would allow it to be handled so carelessly. MNKD, SNY, and the FDA are all to blame, what a shame. And now that people are figuring out how to really use Afrezza, it’s even more apparent how bad they screwed up. I just wonder how long it will take for the Healthcare System to finally realize how wrong they are to make it so hard to just get a prescription that’s covered by insurance. Eventually they’re all going to look either extremely crooked or dumb. 😎 I know your intentions are good but please avoid giving medical advice like this. Yeah it may work for some/many but this is not risk free. Hypoglycemia is still a real risk. Frankly, there are long time MannKind shareholders who are much more knowledgeable about correct dosing of Afrezza than many doctors. RSR was absolutely correct with his advice, which was no different than if he had noticed his colleague holding the inhaler upside down which spills the powder. |
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Post by mnholdem on Dec 22, 2019 14:02:59 GMT -5
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Post by mnholdem on Dec 21, 2019 20:26:24 GMT -5
And then with the kids in the trials they gave them Afrezza and then took them on a walk before they went to lunch. 20 min to early. Yes. That event happened to be reported early during the current pediatric trial. In fact, it may be happening more frequently than desired, so it's critical that Dr. Kendall makes certain that the timing of each dose is one of the data points recorded during the Phase 3 trial. It can be extremely difficult to convince endocrinologists, when they've become so accustomed to dosing RAA insulin 15-20 minutes pre-meal for decades. If MannKind screws up the Phase 3 trial cohorts, it will likely be devastating to the company. |
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Post by mnholdem on Dec 21, 2019 10:54:00 GMT -5
A stupid question from a non-diabetic: Although this study showed almost a 50% reduction in hypoglycemic events using Afrezza as opposed to asparte insulin , there remained a worrying incidence of hypoglycemic events -- more than 1 per participant -week on average. Does a more recent study using strategies of multi-dosing during meals in conjunction with a CGM show significant further reduction in incidence of hypoglycemic events? Many thanks. As I recall, Alfred Mann once pointed out that many of the earlier trial doctors were dosing too early before meals, which caused more hypo events than was expected. |
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Post by mnholdem on Dec 20, 2019 21:03:11 GMT -5
I expect that shareholder authorization of $60-$100 million worth of additional common stock will be on the Proxy for next year’s annual shareholders meeting.
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