Replies to post #222357 on Biotech Values

[dewophile]

RVNC/EOLS

CP regarding the EOLS toxin. I found it an interesting read even if you don't think it is relevant at this point to the approval prospects of the drug in question:

https://www.foleyhoag.com/-/media/files/foley%20hoag/other/final%20new%20packet_medytox%20cp_12-5-17.ashx

[DewDiligence]

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.