Re: The runway is clear....
in response to
by
posted on
Dec 08, 2018 10:42AM
True. However, there are very important boxes that have been ticked...some of these boxes were not clear at the beginning of 2018.
First, we are about to undergo a 7th data safety review. There is no reason to doubt it won't be an all clear signal...after having gone through 6 of them already and none of the earlier 6 flagged any issues. So that is a clear signal...toxicity is not an issue.
Second, we will have achieved 3000+ patient years any day now. That ticks a key box for the FDA...so less doubt about the drug being eventually approved, at least on data sufficiency grounds. Very important for a potential buyer of RVX...one less box to haggle over, in M&A negotiations.
Third, the mere fact that we are near the end of 2018 means that the drug must be working alright. if not, we would have ended the trials already. So that is a clear positive signal, as has been noted in this forum quite a few times. The longer it takes to get to 250 MACE outcomes, the better it is. Incidentally, I sent IR of Resverlogix an email question, and got an auto reply that he won't be in the office till December 17. That is an interesting point...the IR guy has gone on a holiday, coz he must know the trial is not ending any time soon! Another positive, in my mind.
Fourth, we are funded till top line data comes out. For a company that has lurched from funding shortfall to funding shortfall...that is no mean feat.
Fifth, going back to Tundup's show and tell statement re the data on chronic kidney disease coming out so great. I thought that was a huge positive. If Apabetalone works so well on chronic kidney disease, it has to be working pretty well on CVD/Diabetes indications. And if CKD works, then Dementia has to be an obvious candidate for efficacy. So the Makalu comparison of Apabetalone to Humira is suddenly not so far fetched.
Sixth, the sheer lack of any negative data point so far...has to count for a lot. With such trials, usually there is something that does not seem right...and gives a nagging sense of unease. With RVX, I can't think of a single data point that causes me unease.
Seventh, what is the market telling us? RVX has returned +51% year to date. I have found that the market generally signals who the big winners in the months and years ahead...by looking at the ones who did well year to date. As of Friday close, only 18 stocks in Canada returned 50% or more year to date (I kept it to market caps greater than $250 million to eliminate micro caps). Half of these 18 are weed stocks. This is a remarkable ranking for RVX to be in the top 18, as RVX raised so much capital this year.
In short, while you are right that we are not at the finish line yet...just getting to the finish line in Phase 3 trials of this nature...is no mean feat. That is why I find it surprising that the share price is not close to $4, but is almost back to $3.