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Post by esstan2001 on Nov 10, 2016 21:21:04 GMT -5
hope things continue to get better and if you need to be on insulin, that you can find success with Afrezza
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Post by esstan2001 on Nov 10, 2016 14:26:04 GMT -5
I see vdex as the only catalyst for script sales before mnkd hires more reps in January. Please someone correct me on the following two items if I am mistaken. 1) There is no plan for a trial to prove afrezza causes lower a1c and fewer hypos? The trials are for titration, time in range, and dosing. Also peds approvals. 2) Also, potential rls milestone payments and the 25m sale of the Danbury facility is not included in the runway to 17Q3? These two items represent another means to extend the runway? Thanks. 1. Good question... depends on the sample size of the trial. A1C will certainly be one of hte dependent variables recorded, along with 'real time' blood glucose via CGM; so there is a good chance that this data for dose optimization shows A1C superiority at least when held up against the 171 & 175 trials, and certainly the RT CGM data will be of great value in formulating any new label.
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Post by esstan2001 on Nov 10, 2016 9:37:47 GMT -5
Great job with the cash but I'm still very worried about sales. I really don't feel they have figured out a way to successfully increase scripts yet. You are correct, they have not. But what you should be proud of is that they are performing a lot of due diligence to understand their obstacles. It is almost incredible how patient Mike sounded with regards to the "42 reps", "understanding promotional sensitivity", and not burning cash before grasping Afrezzas best marketing strategy. They are clearly on a different agenda and timeline than us investors and it is a big learning lesson for me as someone sitting on the sidelines. I hope to take this type of experience with me to further my career in the corporate world. Its not about the pressure that is put on you but making the right decisions to do whats best in the allotted time you have. They had an allotted time of Q1 2017 and they outperformed, in my opinion, to allow proper runway to keep understanding how to best get their product in the hands of those who need and want it. They solved and are continuing to solve so many issues in parallel its a bit surreal and its a reflection of how hard they must be working. I really appreciate the approach Mike takes with the data available to them. It sounds like they are squeezing the fruit dry for data that will allow them to better understand how to optimize Afrezza marketing. Though I do not necessarily agree with all of it, it provides perspective when you hear things like the amount of reps was almost half of what we all expected to be out there (42 compared to 70). Yes- Mike really seems to know what he is doing- very analytical, puts all the right metrics in place and takes his next steps based on data. Certainly looks not to be his first rodeo.
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Post by esstan2001 on Nov 9, 2016 20:51:10 GMT -5
I posted this thread a few weeks ago and got a lot of crap for it. Can we relax now? 😁 Now we have other things to be freaked out about. At least with the good news on the conference call I can shift some of my anxiety from MNKD to the prospect of WWIII. well, now that's a relief !
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Post by esstan2001 on Nov 9, 2016 18:22:20 GMT -5
The presentation slides for Ray had 2017 for label submission and epi... Matt commented that epi was being submitted next month... so I am hopeful that both 17's were typos. Was hoping an analyst would call in to confirm, but... oh well. Remaining question which seems obvious, is that the label update submission should be in 2016. Anyone care to comment? I believe it was Dr. Urbanski who was talking at that time, but he said he expects a decision in Q4 2017. He said it will take about 10 months for review and decision from FDA. Yes, I think you are right. Will have to go back to listen. Blows the theory that the label change could be a 30-90 day response. Can you say F- DelAy?
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Post by esstan2001 on Nov 9, 2016 18:11:52 GMT -5
The presentation slides for Ray had 2017 for label submission and epi... Matt commented that epi was being submitted next month... so I am hopeful that both 17's were typos. Was hoping an analyst would call in to confirm, but... oh well.
Remaining question which seems obvious, is that the label update submission should be in 2016. Anyone care to comment?
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Post by esstan2001 on Nov 8, 2016 8:27:09 GMT -5
Puts Sports on that team ASAP too Just add Sla4235 and we'd have the Charlie's Angels of marketing. I can see them being sent on their way every morning by Matt. Sorry to disgust the rest of the females on this board, but at least you wont have to worry about Donald much longer. and baba, so transparent- we all know you are angling to be Bosley.... 😊
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Post by esstan2001 on Nov 3, 2016 11:38:59 GMT -5
We are now ... November ... and it clearly shows how little the company is sharing with / caring about shareholders! Are we going to get another appalling conference call where CEO is begging companies to call them to do business? Of course the "begging" (which was not begging) was done by a prior CEO, not the current one. and likely the final nail in the coffin rendering him the ex-CEO.
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Post by esstan2001 on Nov 3, 2016 11:15:50 GMT -5
I'll give Mike C credit for addressing many of the insurance issues with formulary coverage and Mannkind Cares but this is only one half of the problematic equation that has lead to difficulty with Afrezza. His work has improved things considerably. I'll give him that so kudos. However, all this will be for naught if endos and GPs aren't willing to use Afrezza with their patients. In my opinion, that has always been more of an obstacle than the insurance problems. If that gets better than I think we're on the right track. Bottom line is that sales have to improve and we need insurance companies AND doctors on board to do that. I certainly hope this makes it easier to get the drug for those that want it but availability without demand doesn't accomplish much. Maybe demand comes with the next phase- DTC advertising. All we need is money.
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Post by esstan2001 on Nov 1, 2016 7:22:57 GMT -5
theweek.com/articles/656203/huge-change-coming-insulin-marketNot one word on Afrezza or Mannkind. But hey they do talk about innovation!!!!! Meanwhile the so-far futile quest continues for what experts say would be a tremendous innovation — an insulin pill. Novo Nordisk, for instance, has such a molecule in early stage trials.
A pill is ground breaking innovation in the insulin world apparently. Seriously I'm trying to keep my head high but MNKD has so far failed in exposure to Afrezza my god. And didn't they just put their oral insulin program on hold (I thought that was in the article about them cutting diabetes spending and workforce). If I am right, this Rebecca Robins from THE WEEK does real poor journalist research (or I suppose it is possibe the story went to press before the Novo news).
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Post by esstan2001 on Oct 31, 2016 14:11:31 GMT -5
Apparent re-run of old news...
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Post by esstan2001 on Oct 31, 2016 12:50:59 GMT -5
yeah I think this hurts Emisphere Technologies- Novo was working with their Eligen Technology to get peptides thru the gut...
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Post by esstan2001 on Oct 31, 2016 12:26:41 GMT -5
You are assuming these doctors are advocates. I imagine this list was compiled by surveying doctors and asking the question "would you be willing to prescribe Afrezza?" IMO, most doctors would answer "yes, of course I would be willing" and Boom! your name is on the list. Does not mean they have an understanding of the full potential of the drug and are fighting to convert all of their patients as soon as possible. Docs are getting detailed thru dinner meetings, clinic visits by Mike with user patients, and NP trainer visits. IMO the list should be and most probably is representative of this group.
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Post by esstan2001 on Oct 31, 2016 12:20:31 GMT -5
I think the Epihale avenue might have merits but I think a pharma partner will probably wait until FDA approval before signing on to it. Afrezza's label has been a big deterrent to sales in my opinion, so who's to say that an epi application wouldn't have a similar black box warning or carry the same issues that Afrezza's label wouldn't? I know you can't compare one drug to another but the delivery mechanism is the same; Technosphere. MNKD needs to play a much more active role in the trial design for their epi candidate if they expect to overcome much of the headwinds Afrezza's label has faced. ... The FDA respiratory bar for a rescue inhalation med that gets one time or occasional use is far different than a mutli times per day med for a chronic condition. I do not think Pharma will see the need for FDA approval, just clear evidence from data that it is safe and it works.
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Post by esstan2001 on Oct 28, 2016 8:35:18 GMT -5
Yeah, awake, and not looking for theories. It is just that a couple of times each year or so, there are hiccups in the data due to parts missing or assumptions being made. On such a low base, it is easy to see dramatic differences. Just good to validate (if possible) that's all.
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