Biotech Values

[rph_in_wi]

In regards to an SPA, I had never heard of an up front "binding agreement" to approve a drug. Is this truely what you ment? My understanding was that the SPA was used by companies to make sure that the sponsor/FDA were all on the same page for what would be required for approval. Due to the length of time it takes to complete these studies, the FDA has been known to change their minds in mid stream based on new science or other factors. Granted my experience was from 1996, so new agreements between drug companies and the FDA have surely come about, but I have seen sure approvals for "me-too" drugs being delayed because of trivial concerns.
Interesting stuff though. Thanks for the education,
RPh