TELESTA THERAPEUTICS INC T.TST

Yesterday's Adcom Contradicted FDA Guidance from 2013

[SteveMcM]

In 2013, the FDA had specialists lay out the recommended trial design, and yet the adcom yesterday rejected Telesta's trial as being insufficient ?

What is interesting to note is the highlighted yellow section; this points to the difficultly with a double arm trial. Urologists dislike giving Valstar. That leaves practically no options in the BCG refractory setting for the second arm of a clinical trial.

Also note that for MCNA, in patients with papillary only tumors, the disease-free survival rate was 32% at 2 years in the clinical trial. That's more than 3 times the efficacy of Valstar, and met the threshold highlighted in green below!


https://www.sciencedirect.com/science/article/pii/S0090429513013757

Special Report

Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop

Objective

To summarize the discussion at a public workshop, cosponsored by the U.S. Food and Drug Administration (FDA) and the American Urological Association, reviewing potential trial designs for the development of new therapies for non–muscle-invasive bladder cancer (NMIBC). There have been only 3 drug approvals for NMIBC in the last 30 years, and product development for this disease has been stymied by difficulties in trial design and patient accrual.

Methods

A workshop evaluating potential trial design for the development of therapies for NMIBC was held in San Diego, CA, in May 2013. Invited experts representing all stakeholders, including urology, medical oncology, radiation oncology, industry, and patient advocates, discussed development of products for all risk strata of NMIBC.

Trial Design for Patients With BCG-refractory NMIBC

Placebo-controlled Trials

[DamnYankees]

I  wonder how many fully completed, universally safe, durable response, statistically robust, single arm refractory to BCG trials were collecting dust on the shelf at the time that this eye opening FDA And Urological Association guidance was issued ???  There is no re do on the Adcomm and if they couldn't reasonably address the critical question at hand, how could they be expected

[ragingbull1327]

That may be the most informative article I've ever read on here. I'm surprised that they cannot recall 2013.   The way they move, that was like yesterday to them.   If they don't approve the treatment, then I equate them to ISIS on the most basic of levels.   People don't NEED TO DIE, and without this option, a lot more will.   That's the bottom line.