also, the FDA requires 3 months to look over the study, simply because it was a very difficult study. On one arm, you are looking at the effect of Afreeza for post prandial glucose control, at the same time you are still using insulin for longer action of glycemic control.
Thus, for 3 years or 5 years study; these are not long enough to see the end organ failures improvement in Afreeza arm. Post marketing study on organ failure difference is key to having Afreeza in all diabetic management.-- This is key!!! This is $100 stock to say the least; that is why Alfred Mann hasn't been bought yet; he knows its worth.
If you have an once of knowledge on Diabetes and the difficulty of maintaining euglycemia post-prandally, then you would appreciate what God's gift Afreeza is. The current insulin (even the gold standard does not take care of post prandial hyperglycemia). In other words, there is no insulin in the market currently that would alleviate the glucose immediately after a meal; pts would have to wait an hour or so. In the mean time, their glucose shoots up to 200 or 400 after a meal.
Inhale Afreeza works immediately within minutes, eliminating this post prandial hyperglycemia. The reason why diabetics lose their eye sight, kidneys, and suffer caronary artery disease is because of years in which their body can not tolerate this daily episodes of post prandial hyperglycemia.
Like someone was saying, it would be a crime against humanity to reject Afreeza. It is very much needed. It's not just another insulin. It is an ultra rapid acting insulin that behaves like your pancrease that is very much needed in diabetes to control post prandial hyperglycemia. All I can say, after watching doctor Jay Skyler video; I have a much deeper understanding and appreciation for Afreeza. I am not a diabetic but I am a physician and Afreeza is much needed. The FDA should fast track it. In fact the reason, why they are taking so long is because they want to suggest even doing studies on organ failures among diabetics who are on Afreeza vs. those current treatment. Over the years, Afreeza group will have less eyesight problems, less kidney failures, and less heart problems. This will be one of the post marketing studies, I guarantee you! Of course, pulmonary function test.
if it gets rejected that means all those 27 out of 28 members of the advisory committee were either idiots or they were all in to manipulated the share price of mankind, and make money out of it.
It would definitely be the scandal of a century
tentatively FDA should have their decision by July 15th but technically can they issue their vote before that? Can there be an early or fast track approval?
I am watching this stock daily for any suspected activity. Any sign of coverage is inside infos leak may indicate buyout or partner.
the amount of call options opened is astounding compared to puts. Thus, they may hedge against their short positions. But logically if you are hedging, it makes more sense to buy shares and have puts because the sky is the limit for longs and puts buys you the protection for your loss.
Bahahhaa, 27-1 vote. Your bet is 1/27. You are begging for a miracle to fail, truely a good upstanding citizen!
How do they hold 64 mil shorted shares going into 95% chance of approval in July, and facing possible buyout or partnership before July. They have to have inside infos. Otherwise, they could face major fianancial loss, possible double or triple loss in one day.
my speculation too. I don't know how any shorts could sleep at night holding their positions. They have to have inside infos to sleep at night. Otherwise, one morning they could wake up to a massive short squeeze rally.
The reason why Adcom brought up the conversion ratio was for knowledge; we all know that there is variability among patients based on lungs size, volume, and disease processes that may afffect absorbtion. So, this is not a crucial information to base approval on.
The rate of lung cancer was ONE in how many thousands patients. Isn't that the same odds as the general population having cancer? It just so happened that he fell into the study group. Move on! statistically not significant! The FDA can be jerks and ask for post marketing cancer study and pulmonary function tests. That is all they can do.
Bye bye shorts, run for cover!!! Your days are numbered, watch out for partnership.
it was really smart of mnkd to get Adcom with physicians and experts who can give advise to the FDA mo rons who may not understand it fully.
We all know that every patient is different and their response to even SQ insulin is on an individual basis. SubQ10 unit to pt A, may not do the same for pt. B. Hence, for the FDA to inquire about conversion ratio of SQ insulin to inhale Afreeza is as stupid as the members of the FDA who inquire about it. Every pt has different lung absorbtion capacity, lung volume, breath volume,and bioavailabity. Thus, Afreeza, just like SQ novolog dose will rely on an individual basis. As long as it works equally (or even less effective than SQ without concering side effects), then it is approved. Thus, does it really matter whether the conversion is 3/10 vs 4/10?
When SQ insulin came around, which had a variable effect on patients, did they ask for variability range before they approved SQ insulin? Some pt needed 100 units SQ while others need only 10 units to lower the same blood sugar level.
This just points out that the FDA agents need higher education (do they only have BS degree?). It would be sad if the FDA agents don't fully understand how insulin and pulmonary functions work; and they cast their votes without full understanding. The advisory committee are made up of all doctors. They should listen to the doctors who understand these things fully.
$4/sh with the uncertainty that Afreeza was gonna get shut down by Adcom, this clown has no clue. Even if dilution, i don't see a fall below $5.
These shoerts have nightmares praying they don't get partner or buyout the next day I don't know how these guys can sleep at night.
Alfred Mann, if you don't know him, he is the guy who brough us insulin pump and many other inventions. Afreeza is his last and greatest contribution to the diabetes.
give it til mid 2015, then we will talk again. Once you see the comercials and all these diabetics inhaling their insulin instead of sticking themsleves with needles. $200/sh is out of the question? I don't think so,. $30-50 billion revenue on a small company with 400 mil shares.
on July 14th, I will buy this even at $20/sh because of the approval. Currently, yes it is being manipulated with all scare tactics, don't fall into thier traps. The shorts are loooking to cover before mid July. NO one is that crazy to hold their shorted shares against 27-1 odds; there are 64 mill shares looking to buy and cover. My projection is that we may see $10 in June. Sitting on a shorted position must be nerve wracking, not know when mnkd will announce their partner or buyout.
STay calm, hold all your shares or add more to pressure the shorts to cover higher. The ball is in our court; we have approval in July with 27-1 favor. It's like a championship game, longs are favored 27-1; are you betting on the favorite or the long shot?
Those of you who missed out on stockts that gianed 10-100 folds over the years. Mnkd is the next big blockbuster that will make us all rich. Buy as many shares as you can afford. Insulin is a $30-50 bill annual industry. Even if Afreeeza taps just 50% of that, then we are looking at share price in the range of $100-300/shr. The shorts have really narrow vision; they see this company not getting approval despite 27-1 vote from the FDA advisory committee in favor of approval. Thus, the shorts' dream is $5/sh gain while ours is 10 folds and more.
The FDA has to fulfill their fuduciary duty; they can't not turn down a drug or novelty that would help society. But they can get paid by big Pharma to slow things down-- the delay and previous rejctions because of swapping inhalers in the middle of study. They slow things down to make it become hostile takeover. Al Mann knows that and that is why he hired Greenfield. If I was Al Mann, I would go to the chinese (like someone suggested). Nothing gives US companies a bigger threat than taking business abroad to China or Russia.
all joking aside, how can this guy be an analyst the influenced millions of investors? He's not even smart? Does he even think things through?