Post by
DamnYankees on Nov 21, 2015 10:27am
How safe is too safe?
I'm on the tee block in 35 but I am frustrated by my own observation of last evening. I would like to know if there is a way of providing public feedback to the Fda. Not even as an owner of the company. There are some bright people here in our country and I understand that some people have an agenda in these deliberations. Yep, we akl
know that it exists. But, and a very pronounced but, how the fck does an individual on this panel publicly express concerns about a cancer treatment being excessively safe. MCNA is not perfect, we know that. But it did save/improve/elevate/change/extend/ the lives of what 25% as per universal stats, maybe 80%if you ask patients what MCA actually did to change the battlefield for them. It gives people hope, real concrete hope. By all means, vote it down on its lack of merit if necessary, but too safe? Thank you for your time, and we appreciate your efforts in reviewing our proposal.
Comment by
arghh on Nov 21, 2015 11:12am
I wonder if anybody ever gets a chance for a second "kick at the can" and have another Adcom convened with a different question. I believe somebody asked if they could change the question and the answer was no. Probably not, but just thought I would throw it out there.
Comment by
txbioinv on Nov 21, 2015 11:32am
The FDA does schedule second Adcoms BUT only after CRL is issued and company resubmit their BLA. Gl
Comment by
ragingbull1327 on Nov 21, 2015 1:11pm
"The FDA does schedule second AdComs...." of course they do The corruption makes them a MINT
Comment by
ragingbull1327 on Nov 21, 2015 1:15pm
Your question should be "how stupid is TOO SMART"??