|
|
Post by mnholdem on Jan 31, 2020 13:22:41 GMT -5
It would, indeed, be unusual for a Director to get directly involved with international regulatory agencies. That would be management's responsibility. However, since one of a Director's primary roles is the oversight of management, Tony certainly could and should share any of his relevant expertise with the CEO/Officers. That would not be unusual at all for a board director.
|
|
|
|
Post by mnholdem on Jan 30, 2020 13:57:28 GMT -5
No, and management listed countries that they planned to submit themselves (rather than partner), and I don't believe Australia was one of them. Perhaps Hooper will help find a partner. But best case sales there would still be years away. CEO Castagna stated that MannKind partnered with AMSL Diabetes "t o accelerate patients’ access to Afrezza in Australia." (May-2019) "Under the terms of the agreement, AMSL Diabetes will be responsible for obtaining regulatory and reimbursement approvals to distribute Afrezza in Australia. AMSL Diabetes will also be responsible for sales, marketing, and customer support and distribution activities. MannKind will retain responsibility for supply and manufacturing of Afrezza."Responsibility for obtaining regulatory approvals has been assign to Cipla (for India), Biomm S.A. (for Brazil) and AMSL Diabetes (for Australia).  |
|
|
|
Post by mnholdem on Jan 30, 2020 13:30:29 GMT -5
I've stated this before, but it's worth repeating. The Phase 3 trial must include data points that enable MannKind to filter out any non-compliance at the multiple trial sites. We've already heard of at least one Phase 2 trial participant who was dosed WAY too far ahead of the meal. This is an issue that greatly concerns me because many healthcare professionals are scared to death of insulin. There may be an inherent bias to play it safe by administering Afrezza the same as you would with injections. If that happens a lot, the trial results will be skewed to display unusually high levels of hypoglycemic events. Trial participants simply MUST NOT BE dosed too early because of Afrezza's rapid onset of action. At the very least, MannKind must have a way to filter out the data for any patients that were not dosed properly during the trials. The bottom line is that it is entirely plausable for Afrezza to miss it's primary endpoints of reducing A1c in the pediatric population. Even the risk of missing non-inferiority is possible. The reason is twofold: early dosing and under-dosing of pediatric patients. These issues are why I pray that the trial protocols have been designed with the FDA to make mandatory that trial sites record the exact number of minutes in which Afrezza was administered each participant before s/he eats their meals. We're dealing with two decades of bias regarding insulin, its dangers and perceptions about the correct ways to safely dose patients. Doctors and nurses are human and we're talking about administering insulin to children. I'm hopeful that Kendall has a handle on this and that his team will be monitoring for any problems. Since the FDA doesn't like the drug-maker getting too directly involved with trials sites, it's my sincere hope that the protocols have been designed in such a way as to quickly identify non-compliant dosing. Dr. Kendall has shown us before that he is paying attention to this detail when he presented study evidence that enable him to separate and to present remarkable results for patients that complied with Afrezza protocols. |
|
|
|
Post by mnholdem on Jan 29, 2020 12:45:55 GMT -5
I did find it interesting, however, that Tony came on board having purchased more shares of MannKind common stock than the current CEO has. |
|
|
|
Post by mnholdem on Jan 28, 2020 13:45:48 GMT -5
I remember that... it was when we first discovered that Andrea no longer worked directly for MannKind Corporation.
|
|
|
|
Post by mnholdem on Jan 23, 2020 18:37:28 GMT -5
Give Brendan a call.
|
|
|
|
Post by mnholdem on Jan 21, 2020 20:18:16 GMT -5
I doubt it's the historical "January Effect" but it could be related to December tax-loss selling of MNKD and the 30-day wash rule. Investors who sold for tax purposes in mid- to late-December are now free to buy back in. The volume seems to be too low to indicate pending news although MNKD has been mentioned in a couple Hot 2020 Biotech Stocks articles. It could be new blood.  |
|
|
|
Post by mnholdem on Jan 21, 2020 20:08:19 GMT -5
Right. The good ol' days. I remember posting those MannKind patents for chemical warfare inhalants, as well as encouraging management to seek defense department funding. |
|
|
|
Post by mnholdem on Jan 20, 2020 16:13:45 GMT -5
radgray, you seem to be suggesting that the company's management team should not be held responsible for Wall Street's lack of interest. If so, then I respectfully disagree. Today I heard for the first time from a shareholder that their broker referred to MNKD as a "zombie stock" that's basically dead in the water in regards to options activity. That is quite disturbing to me that LEAPS haven't been released and, if I'm not mistaken, it is the first time this has happened since the company's IPO. I'm saying the market makers(whomever they may be) who provide the selection of options changed their strategy, independent of the actual circumstances of the company. To me, they probably thought they'll make more money offering fewer choices. Perhaps this is the first sign of normalization. A little speculative company like ours doesn't need so many options anyway. I don't believe Mnkd management directly has anything to do with the market makers' restructuring of derivatives offerings. You have a point in that fewer strikes may improve liquidity. |
|
|
|
Post by mnholdem on Jan 19, 2020 15:35:38 GMT -5
radgray, you seem to be suggesting that the company's management team should not be held responsible for Wall Street's lack of interest. If so, then I respectfully disagree.
Today I heard for the first time from a shareholder that their broker referred to MNKD as a "zombie stock" that's basically dead in the water in regards to options activity. That is quite disturbing to me that LEAPS haven't been released and, if I'm not mistaken, it is the first time this has happened since the company's IPO.
|
|
|
|
Post by mnholdem on Jan 17, 2020 5:47:17 GMT -5
Stay timed...  |
|
|
|
Post by mnholdem on Jan 10, 2020 16:11:46 GMT -5
How does the Biomm deal work? Is Mannkind simply a wholesaler selling to Biomm or does it get any sort of royalty as well? Personally, I think that shareholders have a right to know the answer to this question. |
|
|
|
Post by mnholdem on Jan 2, 2020 10:07:51 GMT -5
How is an article that clarified that the India drug regulation agency will require clinical trials before Afrezza can be reviewed for sales in India should be considered FUD? Please explain?
|
|
|
|
Post by mnholdem on Jan 2, 2020 5:35:34 GMT -5
Thank you! I thought that there had been a thread but I couldn’t locate it.
|
|
|
|
Post by mnholdem on Jan 1, 2020 15:39:48 GMT -5
|
|
