Post by
SteveMcM1 on Nov 23, 2015 4:36pm
At This Point, Telesta Management is Key
In my opinion, an FDA approval at this point is completely dependent upon management's ability to discredit the negative adcom votes, and appeal to the critical unmet need in the bladder cancer space. The question is, does current management of a small, Canadian pharma company lacking big connections in Washington DC, have the ability to sway the FDA?
The fact of the matter is, based upon historical precedent, the likelihood of an FDA approval after adcom rejection is rare. The only hope is that management can narrow the indication (to only cysectomy ineligble/cysectomy refusing patients), and discredit arguments brought forth by the adcom.
Adcom members spoke of the following items when rejecting MCNA. It appeared that a number of the adcom members were knowledgable about clinical trials in general, but did not understand the past, current, or future landscape of the bladder cancer market, for the reasons mentioned below. Underlined items represent issues brought up the adcom.
Racial composition of clinical trial being entirely white: while this is a valid point, the FDA needs to remember that the Valstar clinical trial had a patient base 98% that was 98% white. Therefore, the superiority of MCNA to Valstar was NOT dependent upon the racial composition of the clinical trial.
Single-arm, relatively small trial: In 2013 the FDA held a conference to discuss how a bladder cancer clinical trial should be constructed. The commitee could not agree which treatment should be used in the control arm, but agreed that BCG was inappropriate, and a placebo was unethical. Valstar is out of the equation because physicians generally hate using it.
As a result of the above, any company attempting to recruit for a dual arm trial is going to run into a number of difficulties. Bionche tried to recruit using Mitromycin as the control arm, but ran into a number of difficulties recruitng due to the small patient pool to recruit from.
The FDA advisory panel agreed that a single arm trial could be appropriate if certain efficacy results were achieved; MCNA , met these endpoints. For some reason, this fact was never mentioned in the recent adcom meeting.
Other treatments on the forefront; Gemcitabine currently in a phase II trial, could be a viable option soon: FDA should investigate the performance of Gemcitabine in these trials. In one recent trial, Gemcitabine underperfomed a placebo in terms of progression free survival. I wonder what the motivation of the adcom member who mentioned Gemcitibine was. Protecting Eli Lilly's interests?