Re: Naz listing?
in response to
by
posted on
Apr 19, 2019 12:51PM
No real knowledge, and not really qualified to comment really, other than a guy who has been around the medical industry for 30+ years, and waited, and waited, and waited for many things to get thru the FDA at times along the way ......
But my sense is that:
1. End of trial (250) - doesn't do much except to say we made it without getting shut down for safety or "big" red flags, but THIS is HUGE for a new drug in trials! Plus it is now time to actually pay attention. I don't expect a huge pps jump till top line (if then?) personally, unless an itchy BP trigger finger decides to take a BIG risk/gamble now at a better price ... not likely.
2. Top Line endpoints met - think it will begin to get pretty serious, as the investment risk goes down considerably. Still unknowns with Renal, Cognitive, and full scope of CVD. Still risk with FDA (never certain! - paperwork, suspicious data, protocol violations, insider malfeasance, other weird things can occur). But at this point, I would think deals/discussions begin to "take shape" in a more meaningful way. Rumors could spur pps also, hard to keep a lid on multiple conversations, as easy as just conceling blinded data.
3. Full Data for CVD, Renal & Cognitive sub-studies - If all good, pps is "probably" going to grow in concert with "potential" market opportunity for all three potential indications. Getting closer and closer to low risk investment, with just the FDA final approval looming (still a risk).
4. FDA Approval - If RVX-208 is approved for CVD, plus strong data and potential indications for Renal & Cognitive, and RVX/208 has not been purchased yet, this could be explosive for pps.
I won't hazard a guess at pps numbers along the way, I don't want to be that speculive, but we have all considered the market opportunity & projected pricing here :) But I would envision a "slight" move upward till Top Line, then a nice "little" jump at Top Line, and a bigger jump at Full Data ..... and probably huge contingency deals in place prior to, and in anticipation for approval, potentially.
Things I will be watching along the way ... 1. pps spikes/drops at inflection points possibly signalling word leaking, 2. financing moves/partners along the way to FDA approval, could signal who (and how) is stepping up, 3. company language and confidence, 4. additional listings (Nasdaq?), 5. airport activity in Calgary lol.
For those (big investors & BP's) that think this is truly a potential blockbuster, the pressure is going to continually GROW to make their move as we progress thru the continuum of checkpoints & milestones which will be continually decreasing investment risk and illuminating the broader opportunity with data coming in the 3 areas for potential future indications.
I love roller coasters ... we have simply been standing in a long 2 hour line in the hot sun, now you can hearing the clicking sound climbing the hill to the first BIG thrill, and hopefully many more thrills along the ride.
I remain optimistic due to the DBSB successes, past data, continued investment money, the company's strangely quiet and confident demeanor (no FA still blows my mind), and the science and timing for epi-genetics in the marketplace.
I really do think this is a breakthrough first-in-class blockbuster coming ... but I remind myself that is what I WANT to think. Data simply MUST be good for CVD for obvious reasons, and to REALLY launch the potential of the other indications with an "FDA approvable" compound for at least the first indication in CVD ... important legitimacy in the short term at least for the other indications, even if they end up being more important opportunities ultimately down the road.
Data ... soon ... all aboard, let's goooooo ...
jmho