Is there a market for type 1's? None. Type 1's make up a paltry 15% of global diabetes drug/device earnings and to top it off type 1's would still have to take injections. So clearly there is no profitable market here.
--will the label require a lung function test prior to prescription? Seems likely, and will this disuade insurers and endos even more? Periodic lung function testing after prescription?
--dosing. Yeah its in units not milligrams (learned from exuberas mistakes) but this does not make the dosing any less confusing. Mnkd shot themselves in the foot here and i gotta say the fda will want full blown transparency here with specific dosing for all patient types.
--exubera and lung cancer. Is it a problem with afrezza? Theres no longterm safety data for this (and no you dumb longs 5 years is not longterm) so we really dont know. As of now the answer is no. But how powerful can guilt by association be? We'll see?
--humoral repsonse in fda label? Inhaled insulin causes spike in insulin antibodies? Point could prove moot but its still there.
--pregnant? nursing? elderly and how old? children and how young? Advair/Qvar or anyone thats ever been on an inhaled substance? Smokers? Previous smokers? Pot smokers? Athletes?
You see these are just a few things that show the fda labeling process for a drug of this magnitude is going to be difficult. Diabetes is not some disease that affects a few million folks. Its globally massive and for that reason any drug that gets approved will be heavily scrutinized and the labeling strict. They wont take chances on a disease population of diabetes size with huge projected growth. There is likely NO way this gets a july 15 decision and i see a 3-6 month delay. If for some crazy reason there is a decision by july 15 then thats because the compromises have been made and the label will be black box type quality. This is the FDA so expect delays. Since Margret Hamburg took over the FDA the approval times have not imp
Not at all. I could potentially fall 25% or more with an approval. Whats dangerous now is that this stock is full of gambling junkies masquerading as traders both mom and poppers and hedge funders. As microcosm, 9/10 posters on this board want a quick pps spike so they can sell and make their rent or move on to the next gamble. Few longterm shareholders actually exist here. I expect fda approval over the next few weeks followed by a pps collapse to $7. From there a steady rise toward $20 over the next 2-3 years as partnership and manufacturing assimilate afrezza to the masses. No doubt the responses below will be the typical penny stock or biotech stock banter by the junkies-
"I can see this company being a major buyout candidate"
"The partnership could be worth several billions"
"Afrezza will be one of the best selling drugs ever...globally"
"$25 after approval...easily"
"I dont see how we trade below $20 with approval"
Or my favorite propaganda piece-
"Diabetics NEED this"
...im sure without afreeza diabetics will drop down and die.
After trading biotechs for years this garbage gets old. Im currently short at $10.5 average and will switch to a long position after approval.
"Shortie gonna get burned"
"This is going to be one of the biggest short squeezes ever"
"You are playing with fire"
"Another adam fuerstein paid shill"
Sorry that i have "no idea" that afreeza is about to change the world.
Inhalation will be tough to get past for many endos prescribing but the high cost of afreeza vs injectibles will be considerable and the insurers will slap it on the platinum coverage plans. I dont see much of a market to be had here aloof from some well to do folks and the rare conditions where people cannot use needles. This is all asuming the label is even favorable to begin with!
I expect a move to $5-$7 with approval and a flat stock until sales data. Partnership and approval are in the bag so already priced in.
Wanted to add that this is not even a drug for an unmet medical need so this only makes the label more likely to adhere to strict protocol.
"$15 on approval"
"$17 on approval"
"We could hit $20+ with approval"
"Massive short squeeze imminent"
"This could be one of the biggest short squeezes ever"
"Once in a lifetime opportunity"
"Shorts are playing with fire here"
Ive brought this up several times previous! The switch to the dreamboat inhaler from the medtone brought with it a whole new can of worms. The medtone was big and the doses of technosphere insulin delivered were large and not accurate enough even though you only needed 3 reloads per meal. The dreamboat increased dosing accuracy for one reason-multiple small doses combined so it could be tweaked. The huge problem is that those "multiple doses" are in the order of 25-35 cartridge reloads per meal. Its a disaster imho. I see no market for this either.
Well its clear you not only dont understand the "behind the scenes machinations" but you dont understand #$%$. Its even more clear you learned about this stock on a message board and are invested with money you cannot afford to lose. Whas even more clear is that you have zero understanding of investment and opened your brokerage accound because online gambling is illegal in your state. You will be summarily crushed when the 3-6 month delay or crl is released. The red flags are littering the landscape here.
Delusional gambling junkies masquerading as investors. Idiots.
They have this stock on their screener and are waiting for a 25% drop at least before considering another position. And even then they will flip it for a quick profit. This stock has now become the victim of day traders, swing traders, shorts, option players, hft and mm's. nothing left here. Telsa Rowe who used to be on this boarf took millions out a this thing. Funny thing was he authored a post right before approval warning of the very thing thats happened here.
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.
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.
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.
Idiot. Thats drug is mostly for type 1 diabetics who represents an irrelevant 10% of the global diabetes yearly drug revenue.
Whats amazing to me is that you are stupid enough to say that like the company is interested in truncating any type of dilution. You are kidding me right? They want to dilute as mich as possible and i would be shocked if they allowed this stock to maintain a price above that.
Well you cant blame a guy for taking profits when a market is at its highest point in history can ya? Sounds about right.
Amen. What we have here is a crowded trade of longs not shorts. When mnkd falls its going to take the dreams, the sobriety, and maybe even the marriage or home of more than a few. Biotech is a brutal sector which should only be broached by pros and with money that should be expected to be lost. It should actually be avoided at all costs. 1/10 companies gets eventual fda drug approval. That means anyone negative on a biotech is right 90% of the time.
If you dont know the answer to this you have zero business playing with options. I expect them to near intrinsic value in a week or two. This approval has been a complete and absolute letdown. As expected.
You damed idiot. How many trial dropouts were there? Dont just partit the positive data you fool. The dropout rate was significant and the fda had a big issue and questions about that. How did mnkd counter? By parading a bunch of fools out to talk about how great it was. Corporate bs.
Insiders selling all the stock they can offload to you idiots. This company is a one trick pony with zero pipeline, massive debt and gimmick product. Who is going to partner with this busted company?