RE:RE:Further clarity needed & size of mkt.They need to clarify. It appears the original trial specified the ability to add an additional 4-5 patients after they got readings back from the high dose cohort. I read it that they already have the FDA and trial team approval to add those patients in if they want. I cannot tell if they can only do it at that dose, or they want to use those additional patients to trial a higher dose, since this is a dosage study. If so, would they need approval?
Secondly, was this add-on originally in their R&D budget or not? Is it worth getting 4-5 more data points over 3-4 months at a higher dose? Open questions they need to clarify.
If the answer to all those is no, then they are just compiling the entire science package around Part 1 of the trial, their lab work around the 4-5 other PDCs they have conjugated (S38, etc...) and their ideas around new ones to try given what their research has turned up (isotopes, SiRNA, radionucleatides, CPI's, etc....). They have some of that data. You could even seek partners for each specific one -- a CPInhibitor player to trial their drug, the immunogherapy guys since the "heat" up a "cold" tumor and make the immune response actually work, someone in isotopes, someone in SiRNA, etc.... It may not just be one partner. Lot's of options and they need to package it all up and hit the road.