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Re: mcbio post# 203920

Tuesday, 08/30/2016 10:02:52 AM

Tuesday, August 30, 2016 10:02:52 AM

Post# of 251565

RVNC—Thought it was interesting the comment about the acquisition of the patent portfolio having both "offensive" and "defensive" characteristics. Makes you wonder if RVNC will try and pursue AGN or others for possibly infringing on some of these patents.

That is the goal. Even a small royalty on sales of Botox in certain indications could be worth a lot to RVNC.

Any concern that Botox won't be used as an active comparator arm in P3? I guess the flip side is nice that just have to beat placebo so lower hurdle.

If it were up to me, I might have conducted non-inferiority phase-3 trials against Botox with a superiority test on duration of effect. However, this would have entailed a risk of missing the superiority threshold, which could have been perceived by investors as a sort of failure. Inasmuch as RT002 doesn't actually have to be better than Botox to succeed in the marketplace, the placebo comparator may be preferable.

Did you finalize your thoughts on what you expect to be the new indication for RT002?

I've ruled out all neuropsychiatric indications (too difficult to prove efficacy), and I'm still pondering whether such indications as plantar fasciitis and TMJ are sufficiently "exciting." The mystery indication might not be related to the IP package acquired from Dr. Borodic due to the recency of that IP deal and the amount of preparatory work typically required before starting a phase-2 trial in a new indication.

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