The great Msb short unwind, page-76

" Or will the FDA go against both OTAT and ODAC recommendations and halt stem cell approvals for everyone even longer?"

we have always suspect a conflict of interest with FDA member, and some will recall in those FDA minutes that they were given 2 opporunities to declare other interest...and they did not.

if we are knocked back again, then who will? ... given several approvals based one no really data, nor safety.... another play could get approval, base on nothing. In this senario the FDA would clearly point the acusing finger of corruption at themselves if not already.

my thoughts have alwasy been, safety first, then does it work... even if unexplained...then the primary endpoints of approvals are those,,,
concern about manufacturing, ability and consistancy will be part of the safety consideration, not about whether a company can actually keep up with demand... that up to a company and its partner to achieve best outcomes.
Safety, and does it work.