Certified Management Consultant and Contract Manufacturing Organisation....is this correct? This is my guess from looking around on the net. The guys that will consult regarding the manufacturing systems = CMC. The site where the drug is made = CMO. Is this correct? My guess also is that the term "certified" would be certified by the FDA...is that correct?
I don't think so since any new CEO might not go along with that. He ( don't forget a "she" is possible too) may wish to proceed in a different manner regarding Davis & Mills.
Perhaps our conversation would stimulate the hallucinating board members. By the way I worked for KP here in Calif. x 30 yrs.
chxfhx, ......ri66 keeps bumping this post over and over again. Because its not his original post I do see it even though I have ri66 on IGNORE. So I am going to put you on IGNORE starting tomorrow to completely wipe ri66 off my view of the message board. I feel bad about it and hesitated to take this action for the last few days. I guess you could remove this post and be done with it and that would solve the problem, but I am not asking you to do that only saying so I don't have to place you on IGNORE.
I got many of those losers on Ignore, including ri66 who just keeps bumping up his posts ad nauseam. Over and over...geez, the guy has no imagination. Contributes absolutely NOTHING to the board. Basically he has the I.Q. of a copy machine. Got him on Iggy so I never see any of his original posts.
That too, we need new blood, my suggestion a week or so ago is Mr. Pyott former CEO of Allergan which recently got bought out. He negotiated the deal with Actavis. He is at the top of the Biotech game and would be a sure winner for ACAD. I don't know if he would be willing to come over to Acadia. But he does live not far from Acadia. We must have someone of his caliber to lead this company. At any point, Davis is out as CEO as far as I am concerned. Davis will be lucky if he and Mills don't get let go. More of the same would not be tolerated by the BOD.
Type Value Conf.
resist. 45.88 2
resist. 39.91 2
resist. 38.29 4
resist. 36.55 4
resist. 34.54 7
resist. 32.98 2
resist. 30.83 5
supp 28.65 6
supp 26.57 2
supp 25.52 2
supp 22.34 2
Recent CandleStick Analysis
Well I believe the BOD will see he is one of the reasons why the NDA submission date was delayed again and so is Mills. I mean they were part of the top 3 in the Leadership Team that failed us. So I think that knocks him right off the short list at some point.
We now have the BOD slot filled, Mr Soland, and most likely the short list for the CEO position is close to being completed. I would say a few more weeks for the new CEO to be announced. It won't be Davis. Pimavanserin is ONE OF A KIND, FIRST IN ITS CLASS drug to treat Parkinson's Disease Psychosis (PDP). And ACAD owns the World Wide Rights to it. The FDA has already reviewed the Phase3 research data and given ACAD thumbs up to proceed with the New Drug Application and has give Pima " Breakthrough Therapy Designation " USA sales will be over 1.1 BILLION and European Union will be well over a Billion as well. There are several other ongoing studies.. The manufacturing arm of the NDA is getting the close attention it should of had last year- it will take some time for new directors & CMO 's to get the systems ready & on line for the FDA evaluations. ..Review the catalyst list-
1) Replacing the CEO with a new Great Leader who can led us to Drug Approval and move the company forward.
2) Possible Partnership with a MAJOR drug company that will assure the NDA will meet and exceed all the FDA standards.
3) 60 days for the FDA (Food and Drug Administration ) to accept the application by about Q1 2016.
4) Upon potential acceptance, FDA could also grant priority review.
5) With priority review, six months pdufa date (Prescription Drug User Fee Act ), without, 10 months. Best guess is July to Oct 2016.
6) EU ( European Union ) filing 6- 9 months post FDA filing. I am thinking not so long for this, say Q4 2016.
7) ADP enrollment (019 study) complete by 2015 Q4 and data by about Q2 2016
8) Schizophrenia maintenance trial to commence 2nd half of 2015.
9) other, eg Autism.
DATES ARE SUBJECT TO DEBATE OR CHANGE AND THEY DO GET DELAYED- this is not uncommon in the world of Biotech. You have to roll with the punches
208K is basically a slap in the face, because consider the MK went from about 4.5Billion to 3Billion in just a few days.
This is exactly what was recommended for me to give several of my patients, Seroquel and I think it was a neurologists although its been so long I can't remember all the details. I retired as a GP back in 2013. As I recall I had a difficult time finding the dose that would work because of excessive sedation with I believe Seroquel ? Also there was some discussion about doing an LP, which I don't believe was done, I forget why. Then when I called the ER the ER asked me if I could do it in my office. Of course I declined and can't remember if he went back to the ER to do the LP.
You get the call from a GP that a patient with PD is having some new Sx of hallucinations...the patient is evaluated in the ER and nothing significant is out of sorts (no infections, labs all ok , CT/MRI normal for age etc) except he has PDP is the ER Dx. Asume he is on type PD meds. What is your recommendation ?
On March 20, 2015, our Board of Directors elected Daniel Soland as a director to fill an existing vacancy. Mr. Soland received our standard compensation package for an outside director, including a stock option to purchase up to 15,000 shares of our common stock under our 2010 Equity Incentive Plan, as amended. Information about our arrangements with our outside directors is included in our annual proxy statement, last filed on April 23, 2014, which includes the description of outside director compensation under Director Compensation. Mr. Soland was not appointed to any committees at the time of his election.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
We are filing this Current Report on Form 8-K/A solely to correct a typographical error under Item 5.02(e) of our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 25, 2015 (the “Original Form 8-K”).
The Original Form 8-K incorrectly stated in the third paragraph under Item 5.02(e) that Uli Hacksell, Ph.D., our former President and Chief Executive Officer and current consultant, was awarded a cash bonus in the amount of $348,000. The actual cash bonus amount awarded to Dr. Hacksell was $208,800.
In accordance with Rule 12b-15 of the Securities Exchange Act of 1934, as amended, the complete text of Item 5.02(e) of the Original Form 8-K as amended by this Current Report on Form 8-K/A is set forth below.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On March 20, 2015, our board of directors approved a retention bonus agreement with Stephen R. Davis, our interim Chief Executive Officer, providing for the payment of cash compensation to Mr. Davis in the amount of $100,000, payable upon the earlier of (i) September 21, 2015 or (ii) our termination of Mr. Davis’ employment without cause. The cash payment will not be payable in the event Mr. Davis’ resigns or is terminated for cause prior to September 21, 2015.
The foregoing description of the retention agreement does not purport to be complete and is qualified in its entirety by reference to the agreement, a copy of which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending March 31, 2015.
Also on March 20, 2015, our board of directors approved a cash bonus for Uli Hacksell, Ph.D., our former President and Chief Executive Officer and current consultant, in the amount of $208,800, based upon an assessment of performance goals