Theralase Technologies Inc. V.TLT

RE:RE:Accelerated Approval

[Rumpl3StiltSkin]

CancerSlayer wrote:

ScienceFirst wrote: There doesn't seem to be a link between Breakthrough Therapy and Accelerated Approval.   There might be, but so far, I haven't found any, in any documentation.  

In the June corporate presentation, AA (projected early 2023) is also presented as being independent of Breakthrough designation.  Not a post-requisite.

To qualify for AA, one has to demonstrate a surrogate point, like a marker pointing to a tumor shrinkage, as per this document:

https://reaganudall.org/sites/default/files/2022-03/RUF_drugApproval_graphic%20%28002%29.jpg

Cystoscopy can confirm "no sign of tumor", like it did for Ph. 1b p#5-6.  So it's clear that we technically qualify.  Could we already have applied for the AA with data on the optimized group so far (p#13-20) and be awaiting FDA response by Jan. 1st???

 

 

 

 

My interpretation/thoughts:

A drug/product that has breakthrough therapy OR fast track status is eligible for the AA pathway as long as relevant criteria are met.....that would be data that is "reasonably likely to predict" both clinical benefit & safety...the latter being equally important.  The data can be based on either a surrogate endpoint (I.e. lab/cystoscopy/pathology results, etc.) or an intermediate clinical endpoint (i.e. earlier durable response data).

Could we already have applied for AA?   In theory, the answer is yes...considering a BTD is not a prerequisite for an AA.  In terms of drug development/trial design, our updated protocol is in place & we are now running in data collection mode, reducing the need for a BTD imo.  In actuality, however, company NRs point toward a BTD filing.   Either way, we could all use a pleasant surprise.

Yep Gents,

That is my understanding also. We are already there now on AA now that we have data looming on the first 25. BTD would just speed the process up by a few months.