pete
Newbie
Posts: 1
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Post by pete on Feb 20, 2014 13:01:47 GMT -5
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Post by liane on Feb 20, 2014 13:09:57 GMT -5
The article is lame. MNKD is under no obligation to release the full data set at this time. They are certainly within their rights to present it at the ADA in June. The author is incorrect in his claim that the data will be on full display at Adcom - any sensitive material will be redacted from the public.
The author is a short - he admits that. It's very clear his intention - to create FUD and bring the price down by any means. I pay no attention to him.
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Post by mdcenter61 on Feb 20, 2014 14:01:54 GMT -5
From everything I have gleaned from YMB from knowledgable posters, the author of this hit piece has a very dubious background. It certainly is a self-serving piece of trash article - timed hit piece.
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Post by thsloppy on Feb 20, 2014 14:23:41 GMT -5
his entire premise is speculation that has zero fact. I love that they are presenting the data at the ADA in a room full of endocrinologists. will make a nice splash. I've been in medical product commercialization for a long time and you would never present poor study results in front of a large audience at a major industry show.
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Post by rak5555 on Feb 20, 2014 16:37:49 GMT -5
The only part where I will partially agree w/ the article was Al's response to why MNKD is getting an adcom this round and not in the past. Al's response was lame at best. A better answer would have been that the prior NDAs were focused on type 1 whereas this NDA includes type 2 where there are much broader implications for the clinical utility across the entire spectrum of patient needs.
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Post by thsloppy on Feb 20, 2014 17:05:56 GMT -5
i agree Rak. The inclusion of the type 2 is the difference as there is no prior precedent. I'm starting to think the AdCom is a blessing because it puts all the evidence to the medical community front and center publicly leaving less opportunity for the decision to be manipulated. Bring it.
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Post by hopetoretire on Feb 20, 2014 19:09:22 GMT -5
The only part where I will partially agree w/ the article was Al's response to why MNKD is getting an adcom this round and not in the past. Al's response was lame at best. A better answer would have been that the prior NDAs were focused on type 1 whereas this NDA includes type 2 where there are much broader implications for the clinical utility across the entire spectrum of patient needs. Or, it seems more likely the truthful answer would be: "We don't know why the FDA called for the adcom - it was solely their decision and any answer we give as to why they called one this time and not the previous times would be merely conjecture. Nevertheless, be assured we will be well-prepared to present our case to the committee in a professional manner. We have absolute confidence in the data supporting approval of our product" Any other answer to explain why FDA does something or does not do something comes off as spin and is easily disputed by doubters. I hope there are no slips at the adcom meeting. They now have 8:00 AM-5:00 PM to make or break a decade of work and well over $2 Billion in expenses. Not to mention my retirement!
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Post by alcc on Feb 20, 2014 20:34:34 GMT -5
i agree Rak. The inclusion of the type 2 is the difference as there is no prior precedent. I'm starting to think the AdCom is a blessing because it puts all the evidence to the medical community front and center publicly leaving less opportunity for the decision to be manipulated. Bring it. Not sure what you mean by "no prior precedent." Exubera was approved for T2. However, I have come around to thinking adcom may be helpful in bringing a broader perspective to the table. Yup, bring it on!
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Post by rak5555 on Feb 20, 2014 21:31:24 GMT -5
"Not sure what you mean by "no prior precedent." Exubera was approved for T2. However, I have come around to thinking adcom may be helpful in bringing a broader perspective to the table. Yup, bring it on!"
Not meaning to split hairs but Exubera had an adcom.
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Post by babaoriley on Feb 20, 2014 22:40:45 GMT -5
And so there is a precedent for for requiring an AdCom when Type 2 is involved, that's good to know, rak, thanks. Thus, it would have been a good answer to lay it at the feet of the Type 2 inclusion. However, it always seems best to answer just like hopetoretire suggested.
That article really made me mad, not all the points were completely without merit, but this line: "After listening to MannKind's call last night, I felt almost bad for shorting this stock. The company's management, in my opinion, has little interest in their investors' welfare, and no interest in telling the true story of Afrezza," is pretty outrageous. Sure, Al would like a huge monetary score, just as he's made dozens of in his illustrious life, but that kind of talk should be reserved for special circumstances, one of those circumstances being where insiders haven't put quite so much of their own money up in the enterprise.
Too many people in the securities industry will do ANYTHING to make money (and most do it knowing that no one will go after them, civilly or criminally)! It's pretty disgusting, be we know it and here we are. I'm not saying we're without greed, speaking for myself, far from it, but I don't think many here would mislead and malign in order to rig the game.
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Post by thsloppy on Feb 21, 2014 15:31:52 GMT -5
and then Seeking has the gall to block my reply which basically called him out on all the misrepresentations and conspiracy theories
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