Re: No mention of efficacy again...
in response to
by
posted on
Mar 29, 2019 03:04PM
Bear, I don't want to put words in your mouth (or keyboard), but you seem to be thinking that there is a reasonable argument for a 5-7 billion valuation at this point in time, with existing BoM trial data risk, given the past data and 50+ % "likelihood" of approval, and given the available market potential? ... Not asking for a commitement lol, just making sure I understand your thought?
Every milestone that goes by could/should solidify or potentially upgrade that position and reasoning a little more, I would think?
So what are the milestones, and sorry if I am being a 5th grader or Captain Obvious? ...
1. Financing - secures completion to full data and FDA approval for commecialization in the future
2. 250 MACE Events - not convinced this impacts pps (until top line data), but it telegraps a real timeframe for data, and make a few BP trigger fingers a little more itchy maybe? ... picture the ending duel in The Good, The Bad, The Ugly
3. Top Line Data mid-Year - now THIS is a BIG deal, and should be VERY impactful ... but maybe still somewhat limited in defining true valuation until full data?
4. Full Data - confirmation of of a straight path to FDA Approval for commecialization, with an eye toward multiple markets (Cardio, Renal, Cognitive) if all study groups are positive, and the 9 DMSB's won't "hurt" the path along with the positive "full" data (hopefully)?
5. Actual FDA Approval - plus confirmation of P3 trials for Renal & Cognitive ... if we get to this "place", I would assume it is "Katy bar the door" ... with a potentially FDA approved RVX-208 and several additional P3 studies for other indications based on positive sub-group study data?
But it can still take 6-9 months for actual FDA approval right, ... after full data, and application to the FDA?
I would think that each of those milestones has potential for strong pps impact along the way, with top line getting it kicked into gear, and full data, and FDA approval setting the sky as the limit?
Make sense, fair "speculative" summary, or am I way off somewhere in my thinking? ... all based on assuming we get "good news" along the way, of course?
I realize there are no guarantees ... waiting patiently for end of trial, ajudication, and the top line ...