right-oh. The PYC thread on HC has a few experienced players, so while the intention is not to teach anyone to 'suck eggs', I was keen to point out the salient points as they appeared to me.
Anyway to your points now...
First up, the point about a PYC claim against ommyc conjugate and chemo from an earlier trial - can you please educate me as to this? I am unable to recall anything like this.
Second, on approvals - Short answer is we do not have any additional hurdles than other cancer compounds as far as process is concerned. But there are a lot of pitfalls, and at least a few iterations. PYC have not even done an animal trial with their MYC inhibitors, so human trials are at least 18 months to 2 years away. They need to make sure BOTH the MYC inhibitor and the CPP are accepted as part of (presumably) an IND application to the FDA prior to starting Phase 1 trials.
It's important to note though - RH claims in private conversation that there are some pharma companies who are prepared to do a funding deal on the basis of animal trials alone. I do buy the spin (for now), because extracellular biologics are not the ultimate end game in terms of targeted therapies.
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