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Re: Joseph_K post# 427913

Sunday, 08/20/2023 3:28:31 PM

Sunday, August 20, 2023 3:28:31 PM

Post# of 464807
Not different set of endpoints but the statistical analysis requirements are lower in exploratory phase 2 trials than in confirmative pivotal phase 3 trials. In another word, for these p2b/3 trials, if the results are great, the company can claim a pivotal trial success and apply for NDA. If the results are less than stellar but still manage to fall into phase 2 requirements, the company can still claim a phase 2 success. We suspect the latter is the most likely scenario here.

The other point is the sponsor is allowed to modify the SAP anytime prior to data lock in phase 2 trials but not in phase 3. It’s consistent with suspected last minute change on endpoint measure to odds ratio on clinic trial website.

See following discussion thread https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170263890

I was also hoping too the pre-specified subgroup analysis could show crossed the board (cog,ADL,sb) mean significance either with 50mg or wild type type, but all we heard so far are Missling hinting on no dose group difference in shareholder meeting and no advantage of wild type in high dose in CC. It’s material information which company is obligated to disclosure if true by now.
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