InvestorsHub Logo
icon url

hojake97

03/22/22 6:33 AM

#41079 RE: G8TSTFL #41078

I’m not sure about that but at least we know that the data summary has been submitted. So one way or another we will finally see the results of the trial data. Very exciting. I would think within a couple months maybe sooner. I guess this explains the big volume on Friday in addition to triple witching day. One thing is for sure is we won’t be waiting till December which was my fear
icon url

drkazmd65

03/22/22 10:12 AM

#41081 RE: G8TSTFL #41078

Good question - my educated guess is 'no', but that's just a guess. I assume that the data is submitted primarily just means that they have done any final data cleaning and have provided summaries in preparation for the actual BLA-related meetings gets scheduled.

I would assume (yes - there's that word again) that does mean that some planning for that meeting is in the works.

Hey - it's progress - if slow progress.
icon url

exwannabe

03/22/22 1:47 PM

#41084 RE: G8TSTFL #41078

So is this an official BLA submission or does a Pre-BLA meeting occur first?


This has nothing to do with a BLA pathway.

Trials are supposed to submit results to the clincial trial registry (clinicaltrais.gov) so they are public. That is what has happened.

An actual BLA is vastly more detailed and not public. Even the fact that it has been submitted is not public unless the company PRs it.