RE: RE: RE: RE: FDA approvals in 2011I agree - $1-$2 is a good reflection of licensing deals that have been negotiated in the past 5 years with similar type therapeutics at this stage of development. Royalties will be where the real money comes in. Pharmagap is still at the pre-clinical stage of development - the FDA approval being referenced is for the first human clinical trial which is expected SOMETIME in 2011. That timeline will not change much if Pharmagap partners because approval of an IND application depends on DATA. That application, which can be volumes of data, requires 30 days to approve.
Then Pharmagap can begin clinical trials. Most cancer drugs take a little more than 8 years from the time they enter clinical evaluation to the point that they receive market authorization for a new drug -so in this case we are looking at 2019 for a licensed drug. Partnering up and possibly getting fast tracked could shorten that number, but by 1-2 years at most. About 16% of therapeutics entering Phase 1 will go on to become a licensed, marketable drug.
There is a LONG road ahead - having FDA approval for a Phase 1 clinical trial is an important step but it is the beginning, not the end of this story. This company should be evaluated by their ability to set targets and milestones and meet them IN ADDITION to sound science and management. Negotiating a partnership agreement should be one of those milestones as they won't be able to fund the next 8-9 years without one. I don't think we should consider the possibility of a licensing deal as a bonus; I think it is a necessity.