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Tuesday, September 21, 2021 12:07:55 PM
I can't speak for Ex, but the concern that I have is that there's not currently an agreement in place with CRL because FDA approval is either uncertain or still very far away.
If you believe the data is bad, DCVAX L shows no efficiency and there is no path of approval based on the data for L then making the assumption that there is no need for a production agreement with either CRL or Advent makes sense. In that case, we have been lied to and mislead and NWBO has bluntly neglected to inform us within 4 workingdays as they should have. I am pretty sure that this is what ex wants longs to believe. I don't believe this scenario to be true at all.
If you believe that the data is as such that approval can be granted then for approval in the US the FDA needs to be convinced that the drug can be produced sufficient and efficiently in the US. There is nothing that I know of why CRL would not want to support NWBO in its quest to convince the FDA in this matter. Yes ok before CRL would commit itself to support NWBO in those rounds of inspection by the FDA a (further) agreement for production must be in place with CRL, but like I said I believe that the details of that contract can only be determined after the date of the trial are known to all parties involved. It would be otherwise the equivalent of ordering a couple of 747's with Boeing without further detail.
It's a matter of mutual interest for CRL and NWBO after topline data/publication shows the overwhelming working of L and why would CRL not cooperate to produce? In short, I don't understand your concerns nor do I see the logic?
I don't mean to suggest that CRL would refuse the business, despite NWBO's past issues paying their bills.
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