The major implication of the complete response in relief of insomnia in 8 out of 8 patients in the trial that had Insomnia symptoms is that given its safety profile would be a near certainty for approval for the narrower indication of relief from Insomnia in ALZ patients that have Insomnia if this holds true in a larger trial. 8 out of 8? Chances of this being a total false signal must be small.
One does not have to look to far to see major MARKET CAP increases in companies that had early success in ONLY TREATING CNS SYMPTOMS IN ALZ AND PARKINSON'S currently sport a 3.5 Bil Market Cap.
ACADIA Pharmaceuticals Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of medicines for central nervous system (CNS) disorders. Its lead drug candidate, NUPLAZID (pimavanserin), is used for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis (PD Psychosis). NUPLAZID is a selective serotonin inverse agonist (SSIA), preferentially targeting 5-HT2A receptors. The Company is conducting a Phase II trial, referred to as the SERENE Study, designed to examine the efficacy and safety of pimavanserin as a treatment for Alzheimer's disease (AD) Agitation. It is also conducting a Phase III, six-week, randomized, double-blind, placebo-controlled, multi-center, outpatient study, referred to as the ENHANCE-1 study, designed to examine the use of pimavanserin in patients with schizophrenia.
AS SOON AS the AVXL ALZ TRIAL IS ANNOUNCED AND AN FDA AGREED END POINT IS SPECIFIED AS RELIEF FROM INSOMNIA IN THOSE ALZ PATIENTS WITH INSOMNIA
What do you think will happen literally overnight to the Market Cap of Anavex? Even if just a third of the ACAD Market Cap it will be be a 400-500% percent gainer. Do you hold your short thesis so close to your heart that you can not face the fact that Anavex is getting ready to move the approval bar from Cognition Approval to the BP favorite target, SYMPTOMATIC RELIEF? and at the same time proceed to try to help the patients with cognition and other QUALITY OF LIFE ISSUES AS WELL?
Also even if only Insomnia Relief is approved the brave men and women of Anavex Life Sciences will have ample funds to advance A3-71.
ALZ and some of these other nasty CNS problems are going to be solved. Who better to do it than the Company "that thinks differently and HAS NO FEAR!
