RE:RE:Lessons learned:"Hummmm,,,,,were we not told our business model was to make deals which would capitalize the 001 trial,,,,,and then it was ,,make deals and to partner on 001?,,,,,, if you are not capable of making deals to the extent required,,step down and pass the tourch on,,,,,!"
The viability of the licensing model ended with Hutchison who ended up talking about a Phase 0 trial as a way out of BTI's predicament. BTI needed human data. Mark Day wanted to capitalize 8 non-human primate trials and take the best drug into a Phase 0 human study subsequently. We only ever saw results from a single non-human primate and we never saw a Phase 0 human study:
"Our plan is to utilize non-invasive, non-human primate (NHP) brain imaging to assess eight targets (across oncology, rare diseases and neurological indications) for their ability to get to the needed site of action in the brain. Only those targets showing actual target engagement will advance into phase 0 microdosing studies. This means we advance only those drugs where we see significant uptake in NHP imaging. The drugs with the best brain uptake will be prioritized for their use in human phase 0 studies."
BTI needed money and needed that human proof of principle data.