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Re: DavidW2 post# 421856

Saturday, 11/27/2021 12:46:37 AM

Saturday, November 27, 2021 12:46:37 AM

Post# of 822090
DavidW2,

The rewrite of the SAP was not done in a vacuum, IMHO. What are the chances the FDA will not agree with the new SAP when their British/European counterparts did? That would potentially result in Britian and Europe possibly approving DCVax-L and America not? What a shit storm this would be! I don't see this as likely for a variety of reasons... the first of which is the FDA recently created guidelines/processes to work with the foreign counterparts for the purpose of streamlining approvals and the most recent FDA guidelines on how they will deal with biologics seemed have been written in favor of NWBO.

Not saying your point of view isn't at all possible... it just isn't probable or practical, IMHO, given (1) the interim results, (2) the push to ramp up manufacturing (via CRL, Flaskwork and Swaston/UK), the FDA's guidelines that appeared to be very favorable to NWBO and a host other reasons.

IMHO...we are at the finish line. But what do I know?




IMHO, if one day FDA agree with new SAP and clinical.gov being updated properly [color=red]similar to European and British agency.[/color] Then NWBO SP will suddenly return to $2s then keeps going higher because TLD news will be out very soon. That is what company is waiting for!


The only thing necessary for the triumph of evil is for good men to do nothing. We live in a time where too many go beyond doing nothing, they boast about their evil deeds and thank their always-loving God for the opportunity.

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