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
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
Von Boy where have you been...I needed you to consult with me on who i could tell to FFFF off and you were not around. So I have had to turn over a new leaf...letting some of the guys out of the Iggy Basement and almost saying something nice about Uli. Please hang around more I may need you later. Oh yeah the comeback look great.
First article...Behind the 8 Ball, but Catching Up. 2nd article Group Lunch Takeaways: Playing Catch Up with Quality Assurance. But is 2 different articles...maybe written about the same meeting. The first article I found on Twitter a few days ago. This 2nd article also written in the same manner, Its very detailed and I have compared them side by side. I consider them valid. Both linked to Cowen Research & Ritu Baral . I guess they could be written about the same meeting, just different topics. But I have no way of proving the dates since I don't see any date on the 2nd article, but I do note on Baral's mention of 1 and a 2. ei Part 1 & Part 2.
..." NDA later this year 1/ " and (... safety profile 2/ )
But is 2 different articles...maybe written about the same meeting. The first article I found on Twitter a few days ago. This 2nd article also written in the same manner, Its very detailed and I have compared them side by side. I consider them valid.
Cowen Research @CowenResearch · 3h 3 hours ago
Ritu Baral - $ACAD mgmt said no change to #pimavanserin safety profile 2/
3 retweets 3 favorites
Reply Retweet3 Favorite3
Cowen Research @CowenResearch · 3h 3 hours ago
Ritu Baral's mtg w/ $ACAD mgmt focused on some outstanding QA issues co. will resolve before submitting #pimavanserin NDA later this year 1/
No there are two different articles. They are both on Twitter and both on I.V. I have a hard time and can't find exact dates for the articles on Twitter...so its possible they are two different articles about the same meeting.