Where we at? We at P3 trial pending and we ain't going it alone!...

Where we at? We at P3 trial pending and we ain't going it alone!

But we haven't done enough to finalise P2 and determine the correct dose
because of poor management, poor trial oversight, poor trial design or poor presentation of trial results, or all of these combined.

To be waiting hoping on the tick for the correct dose at this stage is embarrassing at the very least.

The global model for biotech commercialisation is to out-license the technology to Big Pharma in Phase 1b/2 trials
• Conducting Phase 3 trials, obtaining FDA approval for the product not within the remit of biotech
• Out-licensing is highly dependent upon demonstrating safety in Phase 1 and convincing signals of efficacy in Phase 1b/2
• Licensing deals are generally structured with an up-front cash payment, payments upon reaching certain development
milestones such as entering Phase 3 trials, payment on FDA approval of the drug, and royalties on net sales when the
drug is on the market