Finally finished reading the transcript to AdCommLet me first say that I hope all those suffering from Bladder Cancer may find treatment. I hope that MCNA gets approved and may be able to help treat those suffering with bladder cancer.
I finally finished reading the transcript of the AdComm meeting over the weekend. Here are my observations:
Cons:
1. Most doctors felt that the trial was not up to today’s standards
a. in terms of how the patients were classified. BGC refractory or not.
b. Too many patient types
c. Did not like how the trial was run
d. Follow ups not completed
e. Single arm trial
2. It seemed to me that most doctors were not thrilled that the results of the trial were not cut and dried.
Pros:
1. Most of the doctors indicated that they believed MCNA was safe to use.
2. Many of the doctors felt that MCNA should be studied further
3. 4 out of 5 urologists voted yes
4. Bladder cancer patient voted yes
5. Out of the 24 votes, if you include
a. Yes votes
b. Yes it is safe
c. Yes I would change my vote if the question was changed
d. Yes it deserves more study
You end up with 21 out of 24 votes with some kind of yes.
One of the doctors, who voted “no” and I thought was quite negative throughout the meeting said this:
“But to your concerns which you’ll address, I think we all wanted to vote yes. We wanted to do so. And I think what you’re sensing is that everybody is saying we think there’s something here, please FDA, work something going forward to see that this doesn’t disappear. And one hopes that that’s the case and I felt uncomfortable with the sponsors because I suspect they had very little to do with the design of this study and are now stuck with a study that they probably themselves wouldn’t have designed. So for those reasons I voted no but know that we’re not opposed to it really.”
I'm thinking that it will get approved for a narrower indication.