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dennisdave

10/15/22 2:41 AM

#522049 RE: biosectinvestor #521998

What is not true, has NWBO filed a request for approval with any RA?. That's great news do you have a link to prove that? Ooh, you dont have a link. Thats too bad.

The 21st Century Cures Act. is a fantasy mirage of die-hard NWBO fans.
The EMA is never ever going to approve cancer treatments that the FDA approved without judging and weighing the data themselves. Ever. Moreover, each of the 27 member states will not reimburse any cancer treatment of the EU commission for drug approval has not approved DCVAL L and they will look at the data.


In other words fantasy. Especially since the FDA has proven itself to be corrupt over the Aducanumab incident, the trust between the EMA and FDA is gone. Not going to happen.
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dennisdave

10/15/22 3:35 AM

#522053 RE: biosectinvestor #521998

Not true. New regulations and combinations are reformed under 21st Century Cures Act. And they are clearly in process and have applications directly related to and core parts of their related to the MAA before at least one regulatory agency.



what has this got anything to do with yes or no on skipping Phase 3 as was the discussion, for other solid tumor cancer indications in other organs?

I thought you were talking about project Orbis, my mistake