Biotech Values

[DewDiligence]

Re: RVNC /RT002 worldwide development & commercialization

You ask some good questions; let’s take them in turn.

<<Fosun Pharma already has a growing portfolio of products in facial aesthetics where we plan to gain the first approval for RT002>>

This excerpt from RVNC’s PR simply means that the first RT002 indication for which Fosun will seek to obtain approval in China is in facial aesthetics, presumably glabellar lines.

Can we infer…that [RVNC] won't be seeking a North American partner?

That’s the official company line, but I would take it with a grain of salt.

As a shareholder, which would you prefer and why?

I strongly prefer a Big Pharma / Big Bio partner for North America, and I think RVNC will eventually acknowledge that this is the right course to maximize shareholder value.

What odds would you give to go-it-alone strategy in US/NA?

If RVNC has not been acquired by the time this decision gets made, I estimate an 80%+ probability that RVNC partners with somebody in North America, at least for therapeutic indications.

…regarding new clinical trials [conducted by Fosun for the China market]…

China has been easing its clinical-trial requirements to grant approval for drugs that have already undergone extensive clinical programs elsewhere. (There are various references to this policy change on this message board.) Still, the amount of clinical testing Fosun will have to conduct for approval in China for the initial indication in glabellar lines is hard to pin down precisely.

My expectation is that two successful trials in Chinese patients similar in design to SAKURA-1 and SAKURA-2—but with fewer patients—will be sufficient for China approval. I’m pretty confident that a large, repeat-dosing safety study like SAKURA-3 will not be needed to obtain RT002 approvals in China or anywhere else.