AI
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Wednesday, March 16, 2022 1:36:47 PM
SUKUS: The next one would be a lot faster I think. I think similar to the solid tumor trial they did on DCVax-Direct trial phase 2. Imo.
exwannabe: The Direct P1/2 was first posted in summer 2013. The P2 phase was supposed to start around end of 2014 or so. 8 years later it has not even opened for enrollment. And that would still have not been pivotal.
Direct has now been on the shelf for over 7 years gathering dust.
Only in NWBO-land would this be fast.
Not so fast. You keep forgetting.
UK finalises biosimilar guidance designed to improve on EMA starting point
https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products
