Fda briefing documents-
Efficacy- drug does not work! Put it up against outdated insulin and placebo and guess what happened? only one of the trials was statistically significant! Afrezza could barely outperform placebo! LMFAOx1000000. CRlL or delay? $2 or $4???
Yet still it barely outperformed placebo. Sorry but putting it against outdated insulin and placebo aint gonna cut it. Afrezza does not work. Sorry dude, but the info us right there. You can keep looking at it from different angles to try and shoehorn it into what you want it to be but in the end- it just does not work.
1- im not short
2- i have no position in the stock
3- im here to try and learn as much about the type of shareholders in this stock so i can guage my future position better-
And what ive found is a group of gambling junkies playing with money they cannot afford to lose. They opened brokerages because online gambling is illegal
In their state. They also learned about mnkd on stock boards. A group of delusional idiots with pps estimates that started at $10 and have balooned above $70. I an not short. But you bet yourbagholding #$%$ i will be shortly.
Cool but eh, can you then tell us why adcoms that were positive have ended in crl's? Because according to your greed drunken bagholdin #$%$ that discovered this stock on a message board and are in with money u cannot afford to lose, any positive adcom vote should always end in a drug approval... Clearly thats not the case. Your logic is terrible bro.
Answered none of the posts concerned. You are drunken on greed and caught in the mob euphoria. You will learn a very valuable lesson here.
The fda's concerns were quite honestly almost endless. It was the girst true look we had inside the process and gave us a glimpse into what really may have been in previous crl's. the company clearly had not been cery honest with investors up front. The panel may have said yes but there is zero chance the fda backs that decision. Lets get nostalgic and remind ourselves what the fda was concerned with shall we?
-dosing. The fda didnt understand it and quite honestly i still dont.
-lung function. Lung function decrease observed in many.
-efficacy. Lets be honest, primary endpoints reached but the product flat out just doesnt work guys.
-trial dropouts. Mnkd deserves a standing ovation on covering this up so well
-insulin antibody spike. Question was never answered and fda will not let this slip
-safety data. Insufficient for several endemics. Smokers? Elderly? Children? Etc...
The briefing docs read like the charges in a class action lawsuit. It was one of the worst i gone done seened. There is zero chance this gets approval. In fact i expect a double slap in the face here- a delay followed by a crl.
Agree on all points!!! The adcomm ended in a positive vote but did u read the dossier of concerns the fda had when it released the papers before the adcomm? Holy smokers there is no way the fda approves this gimmick product. Inhaled insulin? Thats a joke right?
70 m shorts is a drop in the bucket. Theres 375M outstanding shares buddy. I seen 250m shares traded in half a day before in this stock. There will be no squeeze and no profits jus angry regretful longs.
400% gain!!!!!???? Are you listening to yourself sir? Even an a wild option trader would shake his head at that. Those guys play for 50% gains and thats considered huge. Hell, a 20% yearly return is considered undoable unless you invested with Bernie Madoff. A 400% gain is massive and the risk involed with bagging one is astronomical.
You really need to step back and look at this marketsphere and think about what you are asaying here.
Lord almighty has it gotten ridiculous around here. Family members dying, posters near death, technosphere the universal cure all, mnkd not going to $15 anymore but $50+, the market for aftezza keeps growing with every post. SeekingAlpha et al pumping so hard they havnt the words to express their euphoria. Great time to be short.
Well you cant blame a guy for taking profits when a market is at its highest point in history can ya? Sounds about right.
Like Christ before me I am clearly prepared to suffer and take these nails whips and spear for your salvation. Your eyes will be opened you blinded fool. You have broken the 1 st rule of trading- dont ever fall In love with a stock.
Richlittle, there is always a firestorm backlash after a CRL. Mnkd is a tiny little irrelevant fish in this pond. They have competitors with some of the biggest mkt caps in the world with connections to the fda. They will see to it that a crl comes priority mail express or a black box label gets plastered on the prescription.
2. Lung function testing
3. Lack of Longterm safety data in certain endemics (children, smokers, elderly etc...)
4. Met need
5. Exubera cancer (guilt by association)
6. Multiple CRL's over multiple years
7. Delay after adcom
8. Insulin antibody spike with technosphere
9. Powerful competitors with deep pockets and fda connections
The fact is the smartest man on this board who has made the most money by far of anyone here sold as well. See Telsa Rowe. Not looking good for u baggies.
By or before July 15 mnkd will receive a notice from the FDA informing them of either a CRL or additional 3-6 month delay. The pps will fall to the low single digits as more dilution, labeling, approval and potential bankruptcy become going concerns. As a biotech veteran who has seen more people wiped out in biotech stocks than at a blackjack table i have observed the 3 following behaviors exhibited by shareholders on the Mb's after their demise-
This manifests first. The message boards become backlogged by several minutes with cuss words, lords name used in vain. There are even the ones who express their anger in placid terms with threads like "well you win some you lose some".
Anger swiftly yields to denial with blame swiftly being placed on the FDA, a specific message board poster, and all types of various conspiracy theories of shorts and hedge funds start backlogging the boards. Many bagholders in denial suddenly turn saintly and start lamenting the loss for those who will not be able to use the life improving drug. Posts like "they just screwed over the diabetic population" or "ruined many lives" will inevitably clog the bandwidth. In reality they don't give a rats #$%$ about the quality of life of anyone.
Eventually regret replaces all as they need to begin to build another bankroll after losing money they could not afford to lose. They look like fools to any friend or family member they enthusiastically told to buy the stock. They search for a silver lining or lesson that wouldn't be relevant even if they found it. You know why? Because at heart they are not investors but gambling junkies masquerading as such and as soon as time has dissipated just enough of the pain of their last loss they will be sinking their money into the next internet pumped losing bet.....
And where am I? Right there with my short selling bucket mopping up the bloody mess of red ink being perpetually spilled by the latest Gordon Gekko wannabe.