Post by
diyodt on Nov 25, 2015 11:21am
the wag
Everyone is weighing in on probabilities here so here's my two cents: The rational wager: MCNA gets approved on limited use. For all those that play the adcomm probability bet, be careful. We fall snugly into the rejected by adcomm but approval by fda template, the most glaring example being Valstar. The reasons are many and they all been stated but here they are anyway: FDA guided us into BLA. It's safe. AUA wants MCNA in their arsenal. Majority of Urologists voted yes. Unmet need. SAFE. Many voters were a qualified conflicted no, unable to balance the risk of progression to metastatic cancer against efficacy profile presented in problematic trial. Ongoing BCG shortage. IT'S SAFE. The big question in this bet is do we get the Not a Candidate For AND Refused cystectomy or just the former. There is a lot of potential candidates in the latter. The doctor just has to say," if you were to refuse removing your bladder then we have some options". The conspiracy bet: No way, no how, is a tiny Canadian biotech going to get fda approval. Find a us partner to sell to asap at a few cents above where we are and call it a day. Full lesson taught to all countries micro bio's. The long term bet: We get limited approval somewhere, maybe in EU with Ipsen help. Struggle to stay alive long enough for efficacy to demonstrate MCNA capability and represent new data to fda going for bcg refractory again. My opinion is fda guided us to get the drug to market. The question always was do you go bcg refractory, or limit to those unable and perhaps those unwilling to have their bladder removed. Fda says: we'll let the adcomm decide that, go for it if you think you can get it. If they would have gotten a yes, fda washed their hands, and the drug is a go. If they say no, limited use is clearly in the best interest of all, approved accordingly GLTA
Comment by
loveshackdave on Nov 25, 2015 11:31am
Really though, isn't someone who refuses cysectomy part of the group that is "not a candidate for bladder removal?" To me those two groups are one and the same and, either way, doctor's are likely to prescribe it as they see fit regardless of the label and insurance companies are likely to pay for it if it delays/elimnates the costs associated with cystectomy or chemotherapy.
Comment by
ragingbull1327 on Nov 25, 2015 12:28pm
What was Valstar approved on? Hopes and prayers?
Comment by
DamnYankees on Nov 25, 2015 11:36am
Like most sensible people, you should have me on ignore, nevertheless I confess to agreeing with 97% of your thesis. I am unsure of your assumption on the "go ahead and try" and we'll work around the Adcomm outcome, but that is one of the top 2 post Adcomm pieces of well devised logic we've seen here.
Comment by
ragingbull1327 on Nov 25, 2015 12:26pm
started from the bottom, now we here!