Theralase Technologies Inc. V.TLT

Opportunity to compare with ImmunityBio data

[ScienceFirst]

From that May 23 request: 

 

May 23, 2022 - ImmunityBio Submits Biologics License Application for N-803 Plus BCG for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ

the FDA has 60 days to respond to ImmunityBio regarding the approval of their treatment against NMIBC.  They should obtain the FDA approval by July 22 approx..

 

If we can synch an interesting news (like durable response data @270 days) couple of days after they obtain their FDA approval as the next SOC (Standard of Care), the market could compare our data with theirs.  That could get us lots of interesting visibility.

[enriquesuave]

They submitted the BLA which after 60 days of accepted and all relevant information included properly, then the FDA will give them a PDUFA date 6 months later, so FDA answer will be in about 7 months.  TLD-1433 will not need a BLA, but only an NDA  much easier and less issues on which the FDA can poke at.  

[enriquesuave]

https://criterionedge.com/manufacturing-and-immunogenicity-are-key-considerations-for-approval-of-biological-products-bla-vs-nda/

[enriquesuave]

And  https://criterionedge.com/what-are-the-major-regulatory-differences-for-getting-a-biologic-product-versus-a-drug-compound-into-the-marketplace-bla-vs-nda/

[CancerSlayer]

Quick summary of how the process works: A drug manufacturer submits a New Drug Application (NDA) or supplemental New Drug Application (sNDA) along with the appropriate fee to the FDA.  Supplemental applications are submitted when a drug manufacturer wants approval to market an already approved drug for a different use. The FDA has 60 days to decide if the application is

[ScienceFirst]

EnriqueSuave ... Thanks for the additional information and nuance.  It makes a world of difference.  And thanks for providing the links to support it.  Well appreciated.  Great work.

[ScienceFirst]

enriquesuave - (6/28/2022 10:56:09 PM) RE:Opportunity to compare with ImmunityBio data They submitted the BLA which after 60 days of accepted and all relevant information included properly, then the FDA will give them a PDUFA date 6 months later, so FDA answer will be in about 7 months.  TLD-1433 will not need a BLA, but only an NDA  much easier and less issues on which