Post by
ROIHunter on Nov 18, 2015 12:20pm
Fast Track
Given that FDA is fast tracking the evaluation of MCNA, they will want to try and get out in front of any or all possible pitfalls. But given the limited amount of data, the difficulty to run trials (since the standard of care was not available) and the desparate need I believe the drug will be approved, likley with many conditions and with the requirement to run a number of further studies.
Comment by
investderp on Nov 18, 2015 12:30pm
It would be insulting to not run anymore studies, given that they could broaden their label/apply for first line treatment/potentially treat other cancers.
Comment by
ragingbull1327 on Nov 18, 2015 12:55pm
.....and why exactly would another trial enhance this? You know what's better than a trial? LETTING EVERYONE WHO IS DYING HAVE A SHOT AT SURVIVAL
Comment by
ragingbull1327 on Nov 18, 2015 12:33pm
The data on Valstar sucks. I don't care how much information they have. It could fill the titanic with how much information there is. It still sucks.