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Post by savzak on Mar 30, 2014 8:10:50 GMT -5
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Post by liane on Mar 30, 2014 9:29:06 GMT -5
Well that was a load of baloney! 63% of the float short??? I think he means 63 M shares short. "Imbalance of lung cancers not favoring the Afrezza group". Where the heck did he come up with this??? I have no doubt Mannkind will have to do a long term surveillance monitoring study, but it won't be based on any red flags seen yet, just normal caution. From the FDA briefing doc: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdfpg 116/248 (read 114 - 166 to get the full gestalt) Dr. Pai-Scherf stated “Lung cancer is the most common cancer in the world and the leading cause of cancer-related mortality. According to the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) statistics, the overall age-adjusted lung and bronchogenic cancer incidence rate during 2006-2010 was 61.4 per 100,000 men and women per year in United States. This rate corresponds to an annual incidence rate of 0.06%. The median age at diagnosis was 73 years. The incidence of lung and bronchus cancer increases rapidly after the age of 55 and is highest between the ages of 65-74. The Afrezza pooled safety population is based on trials conducted internationally. Based on World Health Organization (WHO), the estimated age-standardized incidence rate of lung cancer ishighest in Eastern Europe and Eastern Asia compared to North America.’ ‘A close examination of the four cases of lung cancer reported in the Afrezza TI program indicates that demographics and the available characteristics are consistent with what would be expected in this population. However, the current available evidence does not allow a meaningful analysis regarding the risk of lung cancer in patients exposed to Afrezza TI because of small numbers and confounding factors.” pg 15/248 No evidence of lung neoplasia or pre-neoplastic signals was present in a lifetime rat carcinogenicity study or in a 6-month transgenic mouse carcinogenicity study following Afrezza exposure. |
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Post by notamnkdmillionaire on Mar 30, 2014 9:39:39 GMT -5
What this goes to show you is that I think that there are many who will misinterpret for their own agenda the info that was released on Friday in the BD. It's why MNKD needs to make sure they do a bang up job answering all the questions presented to them by the adcom. It's the panelists that need to see the logic and effectiveness with Afrezza, not the bonehead quasi yellow biotech journalists who have an agenda.
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Post by savzak on Mar 30, 2014 10:13:54 GMT -5
I agree that the lung cancer point is not a well taken short thesis at this point, no matter how it is made. The briefing doc was as innocuous on that point as we could have reasonably hoped.
I studied the document fairly closely yesterday and found that the context added from a complete review added a lot to my overall perception. In short, I feel a good bit better than I did on Friday when I only had time to read the portions everyone was talking and writing about on the boards.
My overall take away is this:
1. The FDA isn't real happy with how management has handled the application in the past.
2. The FDA is unsure about dosing.
3. 171 met end point unless the FDA insists on using the most stringent assumption set with respect to the participants who dropped out.
4. 175 looks solid.
All told, at this point my main concern is the dosing question and how it gets addressed. Any thoughts on this would be very much appreciated.
If dosing is resolved, it would seem we have a fairly straight path to approval for T2 and (I think) still a likely approval for T1.
I'm also a little concerned about the label warnings...not so much for any real effect on future marketing so much as for the immediate effect they may have on partnership or buy out negotiations.
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Post by thekindaguyiyam on Mar 30, 2014 10:48:03 GMT -5
had this been a positive piece from the fool I would have been concerned. Since it wasn't I'm relieved and it seems that every direction they try to give implies the opposite reality to their overt attempts to manipulate.
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Post by babaoriley on Mar 30, 2014 12:09:23 GMT -5
Again, the shorts have really orchestrated this beautifully, as I feared they would. There is huge money short (and of course long, but longs aren't quite so Machiavellian). I remain suspicious of some of the words and phrases chosen in the BD, as that's all the shorts needed to scare longs. It's as if the shorts knew that was coming, so that they would have their chance to get out if they felt they had to. It certainly could be the case that shorts knew that BDs always contain statements similar to what we've seen in ours, and, thus, nothing sinister exists between those forces and reviewer(s). Either way, the shorts have made life more difficult and stressful for longs, myself very much included.
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Post by thekindaguyiyam on Mar 30, 2014 12:23:37 GMT -5
Again, the shorts have really orchestrated this beautifully, as I feared they would. There is huge money short (and of course long, but longs aren't quite so Machiavellian). I remain suspicious of some of the words and phrases chosen in the BD, as that's all the shorts needed to scare longs. It's as if the shorts knew that was coming, so that they would have their chance to get out if they felt they had to. It certainly could be the case that shorts knew that BDs always contain statements similar to what we've seen in ours, and, thus, nothing sinister exists between those forces and reviewer(s). Either way, the shorts have made life more difficult and stressful for longs, myself very much included. With all of the BS; it will not change the AdCom results. |
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Post by jpg on Mar 30, 2014 13:25:53 GMT -5
The shorts had something to do with this market reaction but they could not have been successful (although they didn't do that well as far as share price dropping goes?) without stessed out longs. Dropping 7-8% is, in the big picture, not that big a deal no? What people find harder I think is the anxiety this small drop induced in all longs. This is what shorts count on to take out the stops and exit their hopefully retrospectively foolish short positions.
One of the MNKD boards was particularly entertaining to read. A 'guru' there seemed to have a serious case of anxiety and you could almost feel the tension of followers (including me...). I didn't sell a single share and don't plan on selling anytime soon. Maybe foolish but I have been looking at this for far to long to have an 'anxiety induced' selling episode so close to the end.
I posted the CV an a few opinions of one of the panelists. It is well worth a read. These panelists are not amateurs. I think the April 1st panel is the final say in this approval process. I doubt the FDA would go against this bunch if there is a decisive vote.
I won't buy anymore (I have more then enough for a happy financial future if we are right) but selling now for no real reason makes little sense to me. It might drop a few more percent points Monday. Whatever. April 1st is what counts.
JPG
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