They know exactly what thefda require and they have taken a year to get that exactly right
And I'm sure they've checked in with the fdaaling the way if they had any doubts
Kw knows how good it will be to make an excellent impression with the ind and how much easier it will make the biological license. They are going to have a perfect ind submission imho.
The FDA might require extra information but it's highly unlikely they would reject the application. Not with the team of experts we have informing the process
I believe a rejection is extreemely unlikely for two reasons 1) the fda was gave a roadmap during the pre ind meeting which pmcb is following 2) the trwarment is for an unmet need.... this is big.
Worst case scenario imho is the fda would request more info....which wouldnt delay the process.
However a flat out reejection would likely result is a phase 1 trial to bolster the case. Very much doubt thqt pmcb would sell rights before proven as all the knowledge behind cell in a box is held by pmcb and their consortium
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