There are no human data for PLX-R18.
Exactly. Thank you.
Yea or Nay for the Current Board? Let's hear some intelligent thought on this.
Stop misleading people. A human safety trial is required before it can be approved.
When we see human results, then I will back your statements. Until that time, all else is hype generated through preclinical therapies that don't much matter. The human factor is what counts, period.
On another note, with all these new institutional holders, I wouldn't be surprised to see Zami & his lackey Yaky get the boot at the next shareholder meeting. That would probably be the best thing for this company.
Hey cal. I'm here, but unfortunately there hasn't been much to say. The only tangible positive has been the increase in institutional holdings. Otherwise, the company continues to release fluff while we await the completion of the IC trial. On the ARS front, we're looking pretty good but again it's a waiting game for the initiation of the PH1 human safety trial for PLX-R18.
To me, it seems the company is having a hard time moving forward. For whatever reasons, they still have not started any new trials despite all the hype they created, especially on the CLI front. I also question why there isn't any progress with the orthopedic indications.
It's been frustrating but hopefully things will pan out. Meanwhile, I'm just waiting it out like many others here.
So I seems I was right. The Animal Rule does requires human safety testing. I said it all along, but you refused to believe or at least admit it openly. Another classic example of allo providing misleading information.
"When human trials are not ethical or feasible, as in this indication, the FDA’s Animal Rule regulatory pathway allows for the determination of the efficacy of drugs using animal efficacy studies and human safety data."
There is no human safety data for PLX-R18 as of yet.