Theralase Technologies Inc. V.TLT

help from biostats and regulatory body

[DJDawg]

"The Company is currently working with both a biostatistics and regulatory organization to compile a clinical data report for submission to the FDA in support of the grant of a BTD approval."

This is an interesting comment.

I'm wondering if they are doing the smart thing and engaging a company that does consultations for this exact issue. Such companies are usually staffed with ex-FDA employees to help give guidance on applications. This is the smart move as you need help knowing what to emphasize and what not to. This is one of the reasons some not so great drugs still get support along the FDA track. Because someone knows how to massage the data.

In TLT case, the data doesn't need to be massaged but they do need help emphasizing that some patients were undertreated.

They could also make a stats case around the issue of CR's cases behaving differently and that you would know the answer to that by 180 days. Unlike other drugs with neverending instillations (monthly for some) you would know where you stand quickly enough.

I'm just hoping it means that the company was smart enough to hire someone with special expertise to make this happen.

[ScienceFirst]

On the ASCO-GU poster, their biostatistian was from Harvard: Stats involved Harvard biostatistician: Victor De Gruttola, -  Research Professor of Biostatistics - Harvard T.H. Chan School of Public Health To prepare for the FDA Breakthrough Therapy application, they probably need a more global expertise, as it involves more information, that could resemble, in some parts, this document

[ScienceFirst]

In 2023, out of 45 requests, 10 have been granted Breakthrough Therapy designation. https://www.fda.gov/media/95286/download Since 2012, per year: Previous Cumulative FY CDER BT Totals

[ScienceFirst]

Don't know if we fall under CBER (Biologics) or CDER (drug) Approvals Current CY CDER BT Approvals Previous Cumulative CY CDER BT Approvals

[Rumpl3StiltSkin]

I'd bet real money $$ TLT's Ruvidar falls under CBER, biologics. Any idea if that would impact a BDT or AA application?

[DJDawg]

Hey SF. Where did you find the reference to Victor De Gruttola? Can't find it myself.

[CAinPlap]

Isn't this what Dr Vera was for?

[gojotv!]

,,,which means that the company hasn't yet applied for BTD. I was hoping it was already done, but that explains the terse, tight-lipped response I got from IR when I asked them if the application had been submitted. I never like it when timelines aren't respected, but we'll just have to suck it up... Disappointed.

[chry200030]

So what is the timeline now?  They must have a timeline.  Won't be next week, but give this anothe 18 months and we should have something that would make the share price move nicely..