GREY:ATBPF - Post by User
Comment by
Blazesbon Sep 17, 2020 12:58am
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Post# 31572711
RE:RE:RE:RE:The market is bored
RE:RE:RE:RE:The market is boredCalgaryATE wrote:
It's in the latest MD&A that they expect to start phase 3 in late calendar Q1 2021 or early Q2 2021. I'm assuming it's for the following reasons (stated p.4 of the MD&A): "Additional Development Activities. Upon successful opening of the IND, the Company plans to commence an absorption, metabolism and excretion (AME) study in calendar Q4 2020 to satisfy its regulatory requirement for such a study. In addition, Phase 3-enabling animal toxicity and reproductive toxicity studies for otenaproxesul have commenced in rats, mini pigs and rabbits. They are being conducted in tranches to enable a timely start of Phase 3 clinical trials. Short range studies are expected to conclude in calendar Q1 2021, enabling the commencement of the 12-week phase 3 efficacy trials. Long range studies are expected to conclude in calendar Q3 2021, enabling the commencement of 24-week Phase 3 GI safety trials."
So, i said it would be a year before phase 3 data would be the next repricing event--it depends if the long range studies highlighted above which conclude Q3 2021 will move the needle.
Otherwise the 24-week phase 2 gi safety trials don't finish, optimistically, til Q2 2022. Brother! I hope Stern can make something stronger than lemonade out of the 'significant acetaminophin' lemons management served us.