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News Focus
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bb money

01/17/19 8:37 AM

#563 RE: DewDiligence #562

Ugh. Quite a discount. Maybe this helps put a floor in for us.
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jmkobers

01/22/19 11:14 AM

#573 RE: DewDiligence #562

Dew:

Regarding the price to market for the multiple therapeutic indications currently awaiting or just starting phase 2 trials: can each of these re-use the > 2000 patient safety database recently completed for aesthetics, or would each individual therapeutic indication need its own safety database similar in size to one completed for aesthetics?

I am assuming re-use and that relatively small (200-500) person studies would be acceptable for each of the therapeutic indications for approval. If not, the costs left on the table for approval of the full suite of products currently under development would seem to be mind-boggling.
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DewDiligence

02/26/19 4:30 PM

#654 RE: DewDiligence #562

RVNC 4Q18 results—2019 cash-burn guidance=$148-158M*:

https://investors.revance.com/news-releases/news-release-details/revance-releases-fourth-quarter-and-full-year-2018-results

The FDA agreed that the 351(k) pathway is appropriate for the Botox-biosimilar program partnered with MYL.

Guidance for the RT002 BLA submission remains “1H19”.

*RVNC’s 1/31/19 cash was $296M, according to the CC.