Therapeutic Solutions International Inc (TSOI)

[cablejohn]

by TimGDixon » Sat Dec 17, 2022 8:03 pm

This isn't that at all. We have a regular contact at FDA that Tom calls every other week and so far its not cleared. On the other we could get an email notice on any given day as well.

by TimGDixon » Sat Dec 17, 2022 8:53 pm


We have a very good, high level relationship with fda for being a very small firm. Do you remember the eIND we did earlier ( https://therapeuticsolutionsint.com/the ... ical-tria/ ) this year. We were at the highest levels on that one and the Director of the Office of Tissues and Advanced Therapies (OTAT) gave the OK personally on that one and in fact requested we do dose escalation for that patient, increasing to three transfusions, which is a departure from whats been cleared for phase 3 at two transfusions. We will find out when we find out. I have sitting here a brand spanking new IND for all etiology ARDS ready to be filed if for any reason they shoot our amendment down.