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XenaLives

12/01/16 3:24 AM

#81461 RE: lt2211 #81454

Apparently the FDA disagrees with you and AF.




The placebo-controlled trials that the Agency relies on to support a finding of substantial evidence of effectiveness vary considerably in duration. Treatments designed to treat acute migraine headache typically study only a single headache (because subsequent headaches are intermittent and considered independent events that are expected to respond equally to treatment), while treatments for various forms of multiple sclerosis may have controlled portions of up to 2 years. As a general principle, studies of treatments for chronic conditions should (and do) assess drug effect for at least 3–6 months in a controlled setting, but the duration may need to be longer if the number of events necessary to be able to detect a drug-placebo difference are relatively rare (for example, studies of relapsing-remitting multiple sclerosis (MS) may need to be 1–2 years long in order for enough relapses to occur to be able to detect a between-treatment difference). Some studies of the acute phase of relatively chronic conditions [e.g., acute major depressive disorder (MDD), acute schizophrenia] are relatively brief (2–8 weeks), largely because patients cannot continue placebo treatment for very long (there are too many discontinuations after this duration to be able to adequately analyze the trial). In all instances in which prolonged treatment with placebo is untenable or clinically questionable, protocols contain contingencies to “rescue” patients with effective treatments.





https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534930/

Rubyred77

12/01/16 3:39 AM

#81463 RE: lt2211 #81454

One should know the different phases of trials and their purpose instead of listening to the short chirpers out there. Ph 3, which a pr already stated, will include a double blinded, placebo so on and so forth. A more realistic scam would be to take a failed drug for pennies on the dollar and making people believe you too have a possible medicine for Alz. All the while, knowing deep down that you have nothing.

LakeshoreLeo1953

12/01/16 11:01 AM

#81528 RE: lt2211 #81454

Garbage Study and Insufficient data are two entirely
different things.

While certainly more a trader's attitude than a true believer
in AVXL I am looking forward to peer review being
encouraging enough to spur cooperative deal toward further
trials with enhanced endpoints.

As to AF.....his history and self admitted "Savior" complex
belie the assessment of his Purity of thought.

frrol

12/01/16 11:17 AM

#81531 RE: lt2211 #81454

Phase 2A's are small exploratory POC trials. They're not garbage trials, they're part of the initial clinical development process. Ignore AF and other trolling commentators, and the industry and market conspiracy theories. Keep your eye on the science and results.