GREY:ATBPF - Post by User
Post by
themagicboxon Sep 20, 2021 8:46pm
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Post# 33890672
Perfection is the enemy of the good, Pez
Perfection is the enemy of the good, Pez I'm going to disagree with you there Pez, re the molecule being sold off on its own. Otena could still be sold off as it is in spite of this AME speed bump.
This is a situation of "perfection is the enemy of the good". Despite the elevated LTEs in a small fraction of the participants, its still safer then all the current NSAIDs on the market and all the anit-pyretics such as ASA and tylenol. And thats from a liver toxicity perspective. GI-wise we're golden and proof of concept speaks for itself. We dont need to be perfect, we just have to be better. The medical need is there. Just to give you context, the medical costs of adverse GI events associated with NSAID use likely exceed $4 billion per year. And that number is from a study in 2013. If the need is there, the product will be approved. Thats tylenol's story.
I do beleive they will go to a lower dosage though, as you said, to meet the requirements of the FDA regulators (or as Joe says, the FDA masters haha), and believe they should have enough PK data from the 75mg cohort to make an educated estimate as to where the thromoxane levels and dosing, meets a suitable half life i.e. duration of dosing.
IMO this is stock way too oversold, and will bounce back quickly this year. I dont blame the retail marekt for wanting some further level of assurance. PK and biomarks are gobbldy gook to most people, but to the astute investor it a golden opportunity. As I said before, I am invested in the science, not the management.
Good luck to all.