WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
See full prescribing information for complete boxed warning
Elderly patients with dementia
-related psychosis treated with
antipsychotic drugs are at an increased risk of death.
NUPLAZID is not approved
for the treatment of
related psychosis unrelated to the hallucinations and
delusions associated with Parkinson’s disease
Granted the FDA is just summarizing their BB above, it will probably be much longer and in BIG BOLD SCARY TYPE. They are trying as hard as they can to discourage doc's from using Nuplazid for Off Label use. The effect of a BB Warning will decrease with time as Doc's gain confidence with the Low SAE and comfortable using the drug.
"" Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis. "" ...
Here's my guess - A Black Box Warning - " WARNING: DUE TO INCREASED MORTALITY IN ELDERLY PATIENTS, Physicians are cautioned to restrict use only in patients currently being treated for diagnosed Parkinson's Disease who develop psychosis due to Parkinson's Disease ONLY. And only when the benefit of treatment out weighs the risk of the listed side effects including death. " Off label use of Nuplazid has not been studied and is strongly discouraged due to placing the patient at undue risk.
Spader can you explain #2 (400K shares bonus to employees? ) & #3 ( issuing 3Mil shares) ?
ACADIA PHARMACEUTICALS INC.
3611 Valley Centre Drive, Suite 300
San Diego, California 92130
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
TO BE HELD ON JUNE 10, 2016
You are cordially invited to attend the 2016 Annual Meeting of Stockholders of ACADIA Pharmaceuticals Inc., a Delaware corporation (“ACADIA” or the “Company”). The meeting will be held on June 10, 2016 at 8:00 a.m. local time at the offices of Cooley LLP, 4401 Eastgate Mall, San Diego, California 92121 for the following purposes:
1. To elect two Class III directors named herein to hold office until the Company’s 2019 Annual Meeting of Stockholders.
2. To approve an amendment to the Company’s 2004 Employee Stock Purchase Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 400,000 shares.
3. To approve an amendment to the Company’s 2010 Equity Incentive Plan, as amended, to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 3,000,000 shares.
4. To approve, on an advisory basis, the compensation of the Company’s named executive officers, as disclosed in this proxy statement.
5. To ratify the selection of Ernst & Young LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2016.
6. To conduct any other business properly brought before the meeting.
These items of business are more fully described in the proxy statement accompanying this notice.
The record date for the annual meeting is April 22, 2016. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment or postponement thereof.
Important Notice Regarding the Availability of Proxy Materials for the Stockholders’ Meeting to Be Held
on June 10, 2016 at 8:00 a.m. local time at the offices of Cooley LLP,
4401 Eastgate Mall, San Diego, California 92121
Well not sure who is in the buying mood at this time Friday PM., those on the side lines might now wait till Mon-Tue anyway. I think I would prefer it opens Monday.
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease
April 29, 2016
The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during the course of their illness. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement -- like eating, writing and shaving. Early symptoms of the disease are subtle and occur gradually. In some people Parkinson’s disease progresses more quickly than in others. As the disease progresses, the shaking, or tremor, which affects the majority of people with Parkin
Buddha on a Bed of Jasmine
my death and legacy
shattered life in constant disintegration
hectic input barreling like a locomotive
dust is flying homeless
wind in frantic love rots in the wasteland
the search for wisdom
a total disaster
common sense uncommon
crippled and tortured self inflicted
the Buddha sits right there...
on a bed of jasmine
So say you are long 10,000 shares, and want to hedge by buying puts, how much would you buy and how much would it cost you?
The dilution really doesn't matter all that much, you are correct. It is an odd way to jump into an FDA approval, but its a classic market B-Slap-just when you think you got it figured out..Yes you are correct, its goofy.
Get real with the BB Warning...they always say the worst possible thing that can happen and that is almost always death. Also Good luck to you, I award you the Crecy Brass Balls award, the first ever awarded for your devotion to Acadia, your fortitude, common sense and hard work for 26 yrs of service to your country. Congrats. I salute you.
If you hedge your long position, do you loose money if there is a Short Squeeze? But if say there is no short squeeze and the stock pulls back can you then make money with your hedged position and then make more money if the stock later runs up ?
That was mostly copy & paste from the yahoo stats page on each stock and using their industry browser page. Just go to any biotech stock and click on " Industry " ...then " Biotechnology ". then " Industry Browser "....You will see many stats that you can click on, eg, Market Cap that will arrange in order higher or lower etc.
Detail folks move around all the time, esp if they feel their present job has limited up side. We need them don't get me wrong, to detail a new CNS drug we need people with experience, so its good for Acadia to have them.