Yes indeed, small "s" (safety) indications are primary, and we don't even have the first pk data, only very early indications of low "t" (toxicity). After enough small s occurrences, escalating doses will achieve and quantify MTD (maximum tolerable dose). Other markers are likely known with the first pk analysis, but as yet undisclosed. One would look for these first labs to show "something" related to "e" (efficacy) even before MTD is achieved. In the absence of data, continued cohorts and dose escalation are good signs.
Clearly, statistical significance (robust N) becomes crucial to a big "E" disclosure, but many will be looking carefully at even the smallest cohort sizes, and regardless of N (number of subjects) whatever the first two pk labs samples show will carry some significant implications (of possible small "e" evidence).
What level of data from labs/scans will be disclosed and when? We don't know... this is up to DF (not publications/journals). However, once evidence from cumulative trials positively correlates activated p23 with MRI scans showing decreased tumor size-- then we have arrived, i.e. efficacy with a capital E.
As an investor, if I wait for such positive efficacy evidence to be disclosed, I will no doubt have missed a significant SP move based on a series of prior small "e' evidence. But here's the caveat: one or two, or even a series of small positive markers (e) does not necessarily add up to a Big E. Hence, I fear ongoing vulnerability to whiplash, head-fakes and churn as sequential data points are released.
Which brings us back to issues of hype, volatility and MMs. No doubt we have only seen the first glimpses of a volatile SP, in part because of the sharp rise last month, in part because this is becoming a "story stock" on the OTC. CTIX is in a hot sector (M&A), has multiple novel small molecule drugs, has reputable sponsored trials, expert medical advisory lineage, favorable recent financing, etc.
But here we are on the OTC (wild-west). The MMs love volatility and we saw it again on Friday. They can get away with obvious BS due to lack of regulation, and crying foul can be expensive and distracting to the company (especially if they sue the investment banks/brokerages who are playing games). This does not mean we should hold back from complaining to FINRA when necessary, as it is important for investors to keep the heat on these "regulators."
But the better answer to these "erratic MMs" is to up-list as soon as possible. The volatility will continue here on the OTC and may even get "worse" (both up and down). Traders always try to use the MMs manufactured volatility to their advantage here in the wild-west, but longer-term investors just get tummy aches. The only way to get a fair(er) shake is by getting on a "real" exchange (Leo should consider starting now to be ready with requirements for when the SP stays above $2 for 30 days).
Of course, some people enjoy rollercoaster rides on the OTC and are nimble enough to make money off the swings. But for many who choose to endure the ride (loyal longs) I am certain there will continue to be the occasional need for Dramamine and small white bags.
Back to my shorthand: "small" and "big" letter categories for safety and efficacy might seem like a stretch, but each domain has its own continuum of gradations. Thus, I feel these are useful metaphors designating "incrementally increasing positive markers" (for both small s and e) that will hopefully accrue and morph into a big "E" sometime later this year (for both kevetrin and prurisol).
In sum: small "s" is a necessary but not a sufficient condition for "e"... but glimmers of "e" should be observed even before bigger S arrives with MTD. Clearly, the more signs of little s's and e's the better. I have my magnifying glass out, but its more difficult being many time zones away.
Best to all longs here.
