Replies to post #54173 on Therapeutic Solutions International Inc (TSOI)

[johnnytrader33]

I can envision the news..... we have heard back from the FDA however we are choosing to keep this to the forum faithfooled ... this just in another patent application!

[BigBadWolf]

by TimGDixon » Wed Sep 21, 2022 4:51 am

Codycrusher wrote: ?Wed Sep 21, 2022 4:33 am
I’m curious on the status of general ARDS, that is a big move and it’s very important for phase 3 because you always said the endgame here is to go for general ARDS in phase 3 and for commercialization, so I know how important that is for these trials and all.
I’m excited to see you get the approval and the announcement, I assume it should be any day now because you filed last month and made the PR on the 25th and they have to respond within 30 days I believe so that leaves the end of this month as the timeline and I’m very excited for that.

We have not heard back from FDA yet on amendment but that is just part of the process. Oh I know people want to dig up regulations and then fixate on some number of days the reg's speak of but do what I do and you will see that those things are just ink on paper because they can stop and restart the clock as needed so we just wait patiently. Here's what you need to know and everything in between is called patience/ the minute FDA signed off on our form 1571 that converted the academic phase 2 to a commercial phase 3, the trial began and the trial will continue until we have a BLA with FDA for use in the general population with diagnosed ARDS. Thats it in a nutshell. So everyone needs to come to grips with that. There isn't much else that will come out before BLA other than our published results in peer reviewed journal which will set us up for BLA application. Thats it.