Theralase Technologies Inc. V.TLT

Accelerated Approval

[ScienceFirst]

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???

 

[CancerSlayer]

  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

[Rumpl3StiltSkin]

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.

[Legit62]

I would say the same after seeing all stock option and grants to insiders and Roger and Kristinas big buys , Mandels buys, etc we are very close and may have already applied and will be posted next news release. I say this cause it was the only way for insiders with info to get shares since they cant buy open market if they are privy to news