excellent information and analysis ee03775. Thank you.
Do you believe they will be able to sell this company (most likely private equity) ? How soon ? How would it be valued now?
I own a lot of shares (feel dumb having bought at high in 2013 initially).
Indeed a solid move with monster volume. I mean, wow! I have no clue other than the secondary that we all know about. If you guys find out jfrancis & mpackard, i would appreciate you posting that info. Good Luck to all!
Insiders sell shares for various reasons but they buy shares for one reason & one reason only - if they believe share price will significantly rise in the near or medium term future.
Yes, there was small insider buying back in August 2015, but more sells than buys.
It will be interesting to see if there will be more insider buying in the next 6-12 months.
I am not trying to paint this as "bad" but looking for some positives or an edge to gain more confidence especially as the market conditions worsen.
I read about this new CEO GreenLeaf yesterday and he seems to be terrific. He was at Coram before. Hope he can do the same here at BIOS what he did at Coram.
To be honest, i was not at all impressed with Rick Smith. He sounded very un-assuring during the conference calls, so lack of energy and enthusiasm in his speeches. Clearly, he did not have the best communication skills in my opinion nor did he produce results.
Thanks mpackard. I am holding a lot shares (accumulated by averaging down).
I think we have a long wait here. If they haven't even digested previous acquisitions yet, why do more ? That is my thought.
Good to hear from you jfrancis after a long time.
I am sure you have read about today's developments, Bioscrip will have a new CEO .
What do you think of BIOS now ?
I had purchased last year for $3.20 (after the first CRL) and held it thru the FDA decision this week and paid the heavy price.
Investors are punishing the stock, rightly so for management's incompetence. FDA delays are not uncommon but it affects smaller company like ADMP more so than the big ones.
I had thought management would be wiser and more careful with FDA, after the first CRL. And i bought into InsiderMonkey pump & hype.
Really, the story has not changed much, it is just that confidence in company's management is shaken until they prove their ability to get thru FDA. Investors have short memory.
It hurts so much to give up all those gains this week, but I still plan to hold thru the next approval decision. I am NOT a trader, NOT short but just frustrated.
Broker - The first CRL, did ADMP not acknowledge the CMC delivery volume issue and fix the issue BY REDESIGNING to resubmit the application to FDA ?
who was to blame for the volume delivery issue - Mylan ? FDA ? Sen. from West VA ?
Brokerbuz - I have looked at Mylan's epi-pen and can tell you that product is just superior & sturdy, the casing & all that just so so good, the needle is well protected, and the quality of material (casing etc) is really good. I have not seen ADMP's PFS in hand. Since this product is supposed to do the job of saving the lives (in severe allergy cases) it has to be robust , sturdy, strong, like Mylan's product. If ADMP just realized this or not realized yet, then good luck to them getting PFS approved. Me and my other fellow hedge fund investors have no interest in this company. Since ADMP's product is basically a syringe, i agree with FDA , that ADMP needs to show that this product is robust and will not crack under simple stress.
And stop blaming Mylan for admp's failures.
Wyatt, remember last year it did go below $3 after the first CRL. If the whole market or the botechs in general turn south,, then this can easily go to $3 soon. I think investors are losing patience with the management's ability to get thru FDA process. There is no guarantee that they will not make a new mistake this time around.
I talked with ADMP investor relations today and the guy named Mark seemed very receptive to suggestions, comments & criticism. He acknowledged everyone was frustrated and i let him know that large portion of this blame goes to CEO Denis Carlo. And really he is to be blamed for given his years of experience has not made any difference and has in fact,destroyed a lot of value in doing so.
This human factor study WAS PART OF original PFS NDA. They simply forgot to redo those tests after the new design 'cause they rushed to resubmit the application to FDA.
They(ADMP) think the re-submission and approval decision should happen within the next 10 months.
But i am not so sure if they will not miss something else this time.
Also, asked them about AGN licensing deal as to how this delay will affect it. He also said, they will get advice from Watson regarding this second CRL to help improve ADMP's response this time.
Dennis Carlo tried to market epiPFS without FDA approval in 2010 and was warned by FDA. Just google , you will actually find the FDA warning letter addressed to Adamis & Dennis.
So, even 6 years after that , he can not get a simple syringe device with existing compound approved.
His #$%$ is old, 72 years old and he does not seem to learn from his mistakes. This human factor study was part of PFS NDA.
I mean this guy does not seem like a seasoned pro , he seems novice even at this age.
Since this is an existing drug, the FDA approval process is much shorter but this guy can't even get thru that.
If it is not incompetence then what do you call it ?
lofgrenfan - sorry man, you added this turd to your position. Where does this piece of #$%$ go from here.? No real catalyst in the next one year or so other than APC-1000 & APC-5000.
If they can't even get a simple PFS to clear the hurdle , i mean i have to believe that more compiicated products like inhalers will take them at least 5-6 years to pass FDA.
Dont you think this is an incompetent management at ADMP ? This guy Denis was supposed to be experienced with all this FDA #$%$ and he is 72. And since this is existing compound, FDA process was supposed to be abbreviated , right ?
What do you think about InsiderMonkey morons along with Pumper castor?
Very frustrated the way this whole thing InsIderMonkey has been telling it's subscribers for the past almost two years about ADMP.
These guys are just a bunch of morons at InsiderMonkey namely Dr. Insane Dolittle, editor Meena #$%$ and other low-life writers. They need some moronic hedge fund mamager (who is a pumper himslef, as can be witnessed by his last email after ADMP signed a deal with Watson). This moron has a price target of $65 on ADMP.Despicable.
And add to that is ADMP management's incompetence. Denis Carlo is an #$%$ hole. 72 year old, what the f is he doing there ? Beware Denis Carlo has shady past. The FDA apparently made it clear that this additional testing was part of PFS NDA.
Because of the improvements that were made to the PFS in response to the FDA?s original CRL dated March 27, 2015, the FDA indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing),BOTH OF WHICH WERE A PART OF FINAL PFS NDA. That just tells me one thing about this ADMP management - "Incompetence".
why buy now ? This is a #$%$ management at best. They have been trying to get the approval since 2010(if you dont know just google Dennis Carlo's shady past. He tried to sell this PFS without FDA approval and FDA scolded.