Morgan Stanley take-away points on Provenge prospect
As I guessed some time back, any ex-US partner will be responsible for building their own manufacturing plants for executing the Antigen Delivery Cassette with patients' collected blood. The fusion antigen itself can be manufactured in bulk to supply to the partner(s).
The final 304 results were shared with the FDA who suggested to unwind the placebo arm and let patients cross over to Provenge. As we discussed when it was announced that the control patients could cross over many months ago, this was the strongest signal that the FDA has little remaining, if any, concern whether Provenge works.
Provenge commercialization is expected to be launched in first half 2010. The easy manner in which this was stated by Dr. Gold implies that the company does not expect much roadblock to approval this time.
Since the company rarely if ever states a time frame only to meet it at the far end, they likely expect a launch in April or May 2010 at the latest. That's about when the rest of the NJ build-out is expected to complete. Working this backward 6 months would mean that the BLA should be completed latest Oct or Nov this year. My guess is that the company will announce the expected BLA completion date at the Analyst Day and it'll be within days of that. Then, if the FDA works quickly, we could expect approval much earlier than April next year.
