Since Adcom, Has Anyone Emailed Telesta Management?While many here are excitedly cheering the stock price recovery along, the fact of that matter remains that after a negative adcom review, the liklihood of approval by FDA is rare. I am trying to do my part to help MCNA overcome this hurdle, and was wondering if anyone else is doing similar?
What I have done:
I personally have sent four seperate emails to senior managment at Telesta, and have shared the items in the email on this board previously
1) Contained an article about how other companies have been able to narrow indications in order to survive a negative adcom review, and went on to get FDA approval despite Adcom rejection.
2) Contained data around the racial composition of the Valstar trial (the adcom questioned the racial composition of the MCNA trial being all white. Whites generally respond better to bladder cancer therapy, so the insinuation at Adcom was that perhaps MCNA would not have performed as well if it was given to a more racially diverse group). Well I did some digging and found that not only was the Valstar clinical trial patient pool entirely white, current bladder cancer trials being conducted by Gemcitibine are also entrirely white.
3) Contained data from the Gemcitibine bladder cancer trial that showed efficacy rates that were inferior to a PLACEBO. I sent this aticle because one of the Adcom members spoke extensively about Gemcitibine being in phase II and likely to provide a superior alternative to MCNA in the near future. The actual data does not support this claim
4) A link to an FDA sponsored workshop that took place in 2013, that laid out the required parameteres for a bladder cancer clinical trial. I sent this article, because the panel in 2013 agreed that a single arm trial could be sufficient, and they could not agree upon what treatment should be given in the control arm.
What could be helpful that I have not done:
I recently visited a bladder cancer support forum on the internet and stumbled across a thread from a month ago where a bladder cancer patient was speaking positively about MCNA and letting others know it would soon be available. He was not a stock pumper, just someone who received MCNA therapy in trial.
Several others on the message board eagerly responded and were curious as to how the should go about receiving MCNA once approved. The OP of the thread did not return to let them know the adcom negatively reviewed the drug recently.
Perhaps someone from this forum could provide them with a link to the Journal of Oncology article discussing the MCNA clinical trial results, while letting them know that as things stand right now, the FDA is unlikely to approve MCNA in late February. We want to be sensitive and not make it appear we are simply trying to cause outrage to pump a stock, but the fact of the matter is that these are desperate patients without many options. MCNA provides them with a safe chance at survival.
I believe phone calls/letters from patients who frequent the bladder cancer support forums to the FDA may have a huge influence in the February decision.