Theralase Technologies Inc. V.TLT

AA requires proof of enrollment

[N0taP00p]

From what I've read, the FDA will require that the company being granted the AA satisfy the FDA wrt enrollment numbers for the confirmatory study to be executed in support of the early approval.  It's a tough spot to be in for a small company.  I couldn't tell if there was any leeway or what the numbers should be. But apparently, the FDA is being careful because many companies did not follow through after AA.  Our best bet might still be an offer for a JV with a big pharma for a two-drug combo. I suspect that will have to wait till Theralase actually submits their application with 450 day data to back it up.

[enriquesuave]

I don't see any problems here.  Clearly laid out in FDA trial guidelines for NMIBC is the fact that if AA is granted, then completion of the same trial could be used as a confirmatory trial.  They already treated 50% of patients, so another 50-60 patients from here, and if they get AA, then by that time they may have already enrolled 70-80 patients IMHO Enrolling after AA is not hard

[N0taP00p]

Thanks EnriqueSuave.  Would be happy if that was the case. 

[ScienceFirst]

N0taP00p ...  For AA, you have to look at the specific 2018 FDA bladder document to the industry to have more insights.  See in blue below (on what differentiates us from non-pivotal Ph. 2) and also in green (on why the design of our clinical trial could lead to marketing application).  So the green could the explaination behind the "commercial revenues (projected)"

[ScienceFirst]

N0taP00p ...  For AA, you have to look at the specific 2018 FDA bladder document to the industry to have more insights.  See in blue below (on what differentiates us from non-pivotal Ph. 2) and also in green (on why the design of our clinical trial could lead to marketing application).  So the green could be the explaination behind the "