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Re: dewophile post# 222357

Sunday, 11/18/2018 6:50:34 PM

Sunday, November 18, 2018 6:50:34 PM

Post# of 257628

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.

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