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Re: drkazmd65 post# 43783

Saturday, 06/15/2024 10:17:07 AM

Saturday, June 15, 2024 10:17:07 AM

Post# of 43790

I suspect that enrollment will indeed take about that 'year' - unless some big pharma with deep pockets signs on an starts opening some doors for them and shaking the 'money tree' to grease the skids. That could speed things up by at least a couple of months.

A year would be blazing fast. This indication is about 1/3 the size of the previous trial, so enrollment will be slower. That trial maxed out at about 25/month. I would think 10-15 a month would be reasonable once they get the same number of sites up. But it takes a long time to bring sites up, does not happen in a few months.

I do think that a conditional approval for Multikine, based on beneficial tumor regression data, is possible by sometime in 2026 as well.

That is probably the million dollar question. I would want to see the actual trial design before having a firm opinion, but there are issues here. To my knowledge the only surrogate the FDA has accepted in this area is pCR (pathological complete response, no tumor present in the surgically removed material). The other is that arms cannot be compared as the treatment arm delays surgery while the placebo arm does not.

Clearly this is a huge question one way or the other. OS will of course be many years later if needed.
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