Bio, we will have to agree to disagree on the Aricept approval and number of phase 3 studies reviewed by FDA. It is true, the DPZ trials were much shorter (15 and 24 weeks) back in the mid 1990's. The trend in AD studies over the past 5 years (P2 and P3) has been to do a one year study. In a chronic condition assessing whether a drug is disease modifying, proof of longer term benefit is reasonable --- would DZP have been successful over a year? Maybe, maybe not. MS Phase 3 studies last 2 years. Symptomatic trials can be shorter.
There is no doubt that the SOC for AD is sub-par, double bogey at best like my typical hole. However, this does not change the location of the bar and the regulatory agencies will want to see the primary endpoint met. I do little AD now but did much more last decade. Personally, I think it has some benefit, at least for some, and the annual cost is less than 2 days in a nursing home ($200/year for drug) now that it is generic. I disagree with France (not the first time) and have never had any serious safety issues with it. Hence, to me and I believe to my patients, the minimal benefits are worth the minimal risk/cost. Tolerability for DPZ is mixed, as it is with many drugs. A273 also has mixed tolerability as there were some withdrawals due to vertigo. From a clinical rather than trader/investor viewpoint, I am very much looking forward to the 2/3 results.
Disagreeing with most on this board, I still expect 2 studies will be needed for AD, the ph 2/3 and another ph 3. The DSMB will be tasked with giving a recommendation as to whether the 450 patient study will be increased in size or modified in a pre-specified plan (that will not be made public). A second study will be designed based on the 2/3, size TBD based on statistician recommendations but IMO likely larger than 450, and may screen away patients with variant genes if supported by the initial study.
Take Care,
Doc
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