Replies to post #102798 on Biotech Values

[AlpineBV_Miller]

Genentech had a good inkling that the TDM-1 BLA would be refused. they were taking a calculated gamble. this was not a complete surprise

What's this opinion based upon?

[p3analyze]

You have to be correct: Roched had to have been told by FDA clearly during the pre-BLA meeting that the phase II study would not support an approval.

Was it wishing for FDA to convene yet another ODAC only this time with more representations from the breast oncologists who may be more friendly to TDM1? Or was it plainly desperate to show the new oncology leadership is not a let-down compared to the one that left after the merger?

After watching the Bevacizumab breast cancer ODAC, I walked away with only one conclusion that is the "new" Genentech oncology and its relationship with FDA can each be described with one word - incompetent and hostile, respectively.

What did Roche expect FDA to do with this phase II small uncontrolled study of TDM1 with an ORR endpoint, when the FDA hand-picked ODAC already said 3 randomized controlled large clinical trials of bevacizumab showing unequivacol PFS benefit was insufficient? To accept the TDM1 filing would be making FDA an endless target of mockery for policy inconsistency.

It may not be too far-feteched to theorize this reckless show of defiance by filing TDM1 despite FDA objection could have aggravated the strain with FDA and make it fair game for FDA to deal ROCHE with a harsh bevacizumab odac panel. Now the message is loud and clear.

For once, I think FDA improved by at least trying to be consistent.