RE:RE:RE:RE:RE:RE:RE:RE:RE:28 places in this most recent private placementBack in 2016 Dr. Kamat and colleagues wrote that a clinically meaningful CRR for BCG-unresponsive CIS would be 50% at 6 months 30% at 12 months and 25% at 18 months.
[url=https://https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321095/][/url]
I don't think the FDA ever thought there was any realistic possibility Theralase would achieve a 66% CRR at 12 months. I know that number was bandied about for a few news releases but it was soon dropped.
My speculation is that Theralase, flush with neophyte victory after the successful phase 1b results - (2 out of 3 full dose patients (a 66% CRR)) - tried unsucessfully to pin down the FDA as to what CRR of 25 patients at 12 months would be good enough for AA. My guess is that the FDA wouldn't play until Theralase suggested - "howzabout if we get 66% just like our phase 1b?" and the FDA came back with - "sure kd - you get 66% at 12 months you can write your own ticket - (but fat chance)"
Then Theralase ill-advisedly put this in a couple of news releases as "FDA advice" before they quietly dropped that suggestion.
Just speculation on my part...
Oilminerdeluxe wrote: Thanks. I think it was Dr. Kulkarni who said 30% would be phenomenal. I have doubled up my share count this year. Hopefully, it will be a rewarding decision in 2024. It is a constant feeling of hope and despair. If the right PR comes, that life changing investment is here.
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