GREY:ATBPF - Post by User
Comment by
Pragmatiston Dec 04, 2020 7:39pm
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Post# 32042698
RE:RE:RE:RE:Updates from Dan
RE:RE:RE:RE:Updates from DanMrMugsy wrote: Pragmatist wrote: I suspect the CEO was a tad imprecise in his email. From the latest MD&A regarding current studies:
"They are being conducted in tranches to enable a timely start
to Phase III clinical trials. Short range studies are expected to conclude in calendar Q2 2021, enabling the commencement
of the 12-week Phase III efficacy trials. Long range studies are expected to conclude in calendar Q4 2021, enabling the
commencement of 24-week Phase III GI safety trials."
I do recall Dan saying the studies will finish at different times, going out to the end of 2021. I assumed the only study requred for enabling (FDA meeting and the go-head from them) was the one due in Q4 2020 - toxicity study. Any chance that's correct? With the others to follow and to be provided to FDA as they are completed?
I don't recall him mentioning any specific study. I was under the impression (perhaps wrongly) that the upcoming FDA meeting was more of a consultatory meeting prior to submitting an IND, almost a repeat of the pre-IND meeting but with all Phase 2B results in hand. The company, after all, is moving from trials conducted under Canadian Health authorities to those under the FDA.
Having toxicity study results in hand, and any other study results that might be of interest to the FDA would be a prudent move.