Theralase Technologies Inc. V.TLT

Immunity Bio application accepted by FDA

[N0taP00p]

This was a resubmission of N-803.  Action date is April 23rd 2024.  Last time, the FDA had rejected this same application.  TLTs BTD clock is ticking.  I'm hoping for an update on the timeline next month and how the central pathology lab testing requirements plus additional post-450 day will impact this.  For those that keep repeating "BTD and JV very soon", might want to  prepare new reasons and justifications to refill the echo chambers.

[CAinPlap]

Begrudgingly agree. I have no reason to believe imminent BTD or AA or JV. Will be happy to be wrong but gut telling me we need alot more patient data to satisfy FDA and we won't be told directly this fact until after the financing closes at the earliest.

[Eoganacht]

How do the results of our current trial compare?  ImmunityBio's Trial has been divided into 3 cohorts - Cohorts A, B and C. Only the results of Cohort A can be compared to our trial, as Cohort A represents the N-803/BCG combo treatment of CIS with or without Ta/T1 papillary disease. Cohort B represents the N-803/BCG combo treatment of just Ta/T1 papillary disease. Cohort C represents

[wildbird1]

Thank's Eoganacht, good compilation easy to understand. At the bottom of your post you included a link, I found this in the link, it does complement your post. Page 3-4 Under methods -Patients Exclusion criteria(BCG-Resistant patients that will not be permitted to receive N-803 +BCG). Patients that have a life expectancy of less than 2 year. Patients that have inadequate organ function

[BlueFranky]

Wildbird/Eoganacht, indispensable contributions as usual Thank you... both of you!

[Rumpl3StiltSkin]

Hmm, so they aren't direct competitors. Ruvidar IS for late stage patients...

[N0taP00p]

Thank you, Eoganacht.  Great insights as always.  If approved, N-803 will be one more arrow in a growing set of quivers, restrictions or side effects notwithstanding. We won't know our BTD timeline till next month, assuming they state it in plain english.   Let's just hope all the new requirements don't add too much time.  Add I don't even know what too