Doesn't matter...IND is still going to be filed and if pmcb fulfilled all requests by FDA during the pre-Ind meeting then it will be approved...
If Kenny requests a Phase 2b, it will be rejected. It's extremely doubtful the FDA is brain dead.
That's the beauty of a biotech Microcrap scam - one doesn't know what those items were, or what was really discussed at the pre-IND meeting.
Note the pre-IND was held on 17-Jan. On 24-Jan Kenny PR pumped the Kenny Wonder Treatment would have gemcitabine as the comparison arm. In patients that no longer responded to gemcitabine. Bet the FDA liked that idea! LOL Then came another PR pump 13-Feb-17 with Hidalgo riding to the rescue under the headlines of:
At least 5-FU is closer to reality, although not all the way.
The point is at best Kenny told the FDA he wanted to go "head to head" with gemcitabine. As he stated 1 week later. Then that was tossed, in favor of another protocol a couple of weeks later. So what exactly was discussed with the FDA?
Kenny (aka Crusty the Clown) has been winging it all the way through the process - hasn't he?