I'd also be interested in Logan's reasoning behind that statement. If early Ph2 data stacks up enough to confirm similar or better safety and efficacy as PTX-100 has already delivered, then the drug will not only offer a derisked proposition for financiers to come on board the share registry, but potentially give the company a shot at becoming the first ASX-listed company in oncology to be in a registration trial.
I'm curious about your statement above, @logan123: "My guess is between 60% and 70% success rate, which would put us in a very inviting position." We have yet to even see the trial design. So, are you basing that on the likelihood of each of the following applying:
- More efficient dosing regime
- Inclusion of diagnostic and prognostic biomarkers
- Secondary (or surrogate) endpoints
- Ph2 trial will recruit patients with as few as two prior lines of treatment (vs Ph1 between three and six lines)
There is one mitigating factor to consider, though, and that is the FDA's requirement to lower the highest dose to 1,000 mg/l. Perhaps the data analysis and insights from KOLs and, the fact that we may get to treat less heavily pre-treatedCTCL patients, will help balance the equation.
Are you also guessing that results for our Ph2 may be substantially higher than the Ph1b results because the latter results have yet to be officially disclosed? The study is ongoing and one patient still on the trial (according to a statement made by SYC in a webinar) has achieved a complete response,
I have probably answered my questions. However, I would certainly appreciate your perspective, Logan.
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I'd also be interested in Logan's reasoning behind that...
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