Because Herceptin is already FDA approved and p97 is a human protein (conjugate BT2111), would further rigorous testing still need to be performed on primates before moving forward? Does anyone know approximately how long it could take the FDA to grant BT2111 approval for the compassionate care act, if we were to be so lucky?
With this latest NR, a fast track seems inevitable. People are dying.
What hurdles do we face now?
As JD has stated numerous times, we must show the pharmas we’re moving this thing forward - I agree.
Another question: besides TTU being academia and all and them taking what seemed like an eternity to provide us with results, why did it take so long to get results back when the test only lasted 35 days? Because the results of these tests are so phenomenal, would it be fair to assume the next batch of tests (if required), would be fast tracked instead of back-burnered? I don’t know if Transcend was back-burnered, it just seems like it was. Due to the importance of delivering therapeutics to the brain and what the Transcend test results have shown to date, would this not be of greatest interest, importance, and significance to the scientific community and the world?
And what is going on with the Shire results? Come on...
Just guessing but I feel strongly that we will have a licensing agreement in place, a buyout, or another collaboration or two within two weeks. There has been talk that BTI is “unknown”, which seems to be true according to Kayacker’s post today but that is only the market, the pharmas we care about know exactly who we are and I would suspect they have been watching ever so closely.
Although the SP didn’t move as much as we all thought it would (I’ll speak for us all on that), I think with this news and the inevitable licensing agreements and collaborations to come shortly, BTI will indeed skyrocket to new highs. Timeline will be short imo. I say you've got two weeks. Last chance to get in at these levels.