I thought it timely to repost Martin Roger's reply to DNDNandPRR's question to him (16/4/10) about the effect on PRR of FDA approval for DNDN's product Provenge.
(I hope this is OK with you DNDNandPRR? )
here is what Martin Rogers said:
MR: "Dendreon's PUFDA approval expected 1st May is a seismic shift for Prima and anybody else developing cancer vaccines.
The pathway will now be crystal clear and there is a known, consistent benchmark to reach.
Dendreon have done an amazing job with countless setbacks and now since they will break through it makes everyones job so much easier. I can't emphasise this point enough.
Another thing to consider is if they knew what they know today then they would have had approval a lot sooner.
Also this has been a challenge for the FDA and they have had to think differently. Don't forget the FDA only put out cancer vaccines approval guidelines about 3 months ago. Behind the scenes on this is the patient lobby groups who really want the vaccine.
What an effort and it is great to be up there and doing this work."
end of extract
cheers
Birdseye
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