RVNC/EOLS— I found [Medytox’s FDA Citizen Petition against EOLS] an interesting read even if you don't think it is relevant at this point to the approval prospects of the drug in question…
The FDA CP appears to be a prolongation of a competitive battle between Medytox and the two other Korean manufacturers of botulinum toxin, Hugel and Daewoong, which has been going on since at least 2014. The most attention-grabbing part of the CP (IMO) is Exhibit 5 (starting on page 73), a 2016 sell-side investment report on Hugel that mentions the investment risk stemming from Hugel’s and Daewoong’s non-disclosure of the toxin strains used in their products.
If I had to place a bet, I would say that Daewoong (i.e. EOLS) probably is using the Hall strain and that the CP won't affect the FDA's decision on the DWS-450 BLA. As a RVNC long, I would be happy to be wrong about this, of course.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”