Safe Harbor or not, it could POP the stock and wash a ton of shorts right off the plate. Holding a short position into this Qrpt is very risky. I hope the shorts HOLD their position all the way to $40.
You might also check out MRK, they got some cash to beat PFE to the punch...they could also buy ACAD ...their q rtp will be next week ( ? news?) and their New Drug application is just around the corner.
Not so much another inhaled insulin , Affrezza. There is risk of marketing failure like PFE's inhaled insulin that FAILED BADLY. Lower than expected sales, disappointed shareholders who bought in too high are mounting up daily= Too many bag holders will sell off all the up coming rallies ( if there are any). Does Afrezza have value ...yes. How much...not as much as the Rah Rah crowd thinks. Black Box Warning can be a killer for many new drugs, Stiff competition from those excellent products like Flex Pen's, that has a strong brand loyalty. Patients love their Pen's, require no refrigeration and you hardly feel the needle. Drug insurance protocols which protect the bottom line that will keep the sales less than expected. Generics are always recommended as a first line treatment by ALL drug insurers. Probably only 1-3% of the diabetic population will ever use this drug. Not even close to 10%. The value in MNKD is the technology. If they get other products to market that would really increase the MK. THEY MUST HAVE A PARTNER or this stock will never get off this Short Controlled trading pattern.
Think of the IBB like ACAD...but with a lower Beta or vice versa think of ACAD like the IBB but with a HIGHER Beta.
Type Value Conf.
resist. 30.10 2
resist. 28.78 2
resist. 25.34 3
resist. 24.88 2
resist. 23.75 5
resist. 22.44 3
resist. 22.08 2
resist. 21.54 3
resist. 20.93 9
supp 20.04 6
supp 19.27 4
supp 17.91 5
the Fabulous town of "New Drug Application" and that Hot Hot town of "40 Dollar share". All aboard !!!
They need CASH FAST. They need about 150-200 Million to get production rolling for 1+years. The amount of cash they have now would start up production and perhaps take it about 3-6 months. So either the CEO has to get a partner or....(Ugh) SELL SOME SHARES. So to get about $160 Million at this point he would have to Sell about 20,000,000 Shares at about $8 ( ? lower to make it attractive to Big Investors).
The "special cases " patients who can't inject themselves. eg, Elderly patients who have little help at home. Patients with poor vision/blind. But not nursing home patient where there is always a nurse to give an injection. Patients with recurrent MRSA skin abcess. But not those who "don't like needles", a drug insurance is not going to approve an expensive drug for that. They will want to see a valid diagnosis of Needle Phobia in the chart after an evaluation by a Mental Health provider. So various protocols will screen out a lot of potential users. Now there is always the folks who have money who will demand it and pay out of pocket. Less
Oh forgot one special case...people on high dose blood thinners who seem to have excessive bruising might be a special case. Also anyone with a bleeding disorder might benefit too. You probably can think of a few more.
New Diabetes drug...ah no. its not new - its Insulin. And not even a new way of using it, I believe PFE had an inhaled Insulin product that FAILED. MNKD will have a difficulty time trying to get to market, for sure they need a partner ( unlike ACAD doesn't really need a partner). MNKD needs CASH and has a ton of DEBT. Watch out for the CEO to sell new shares....Their product supposedly might be used in 10% of the Diabetic population...but I seriously doubt it. perhaps 1-3% ( special cases ) . There are just too many generic products and really great alternatives like those Insulin Injector Pens-very tiny needles that you hardly feel, no refrigeration required and High Brand loyalty. Patients LOVE their Pens. Not to mention the Affrezza BLACK BOX WARNING. But the value they have is in their new technology. Now if they can get it to work with other drugs...well that would really help the stock. Trading op....if they get a partner it will pop the stock...but I believe many will sell the High and get out fast. BTW. go look at the headlines on MNKD...some Hedge Fund guy is predicting MNKD will fall by 90%. So in general, it may be a big risk to buy & hold.
Doctor....Hello Mr Diabetic, your recent test shows a good HA1C. How's it going?
Mr(s) Diabetic...Really well. I love the Flex Pen...Its a lot easier than I thought and I don't hardly feel the needle.
Doctor...Great, I knew you would be able to use it easily....
Mr Diabetic.....Oh by the way have you heard about that new insulin inhaler ? Afunza or something?
Doctor....Yes, Afanza, but really its not that new of an idea, there was another one and it was a big failure.
Mr. Diabetic....Oh yeah i remember that , but is this new one better.
Doctor.....Well the company seems to believe it is, it might be for some patients. But keep in mind there is some type of warning on it. But you're doing OK and i don't see any reason to change. Hey did you see the Dodgers beat up on the Giants last night...WOW !
Keep in mind these instruction a mostly for first time users. They are fairly easy. When a patient is given a Flex Pen for the very first time they will have a brief sit down with the doctors nurse. Takes about 10 min. They can sit and watch the video on the internet too. Its really simple. Patients already using the Flex Pen, LOVE IT. there is strong brand loyalty. So putting up instructions would only convince a person who has no knowledge
of this subject...it will not convince a current PEN user, a doctor or the drug insurance provider that will approve Brand name drugs.