Replies to post #710474 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

What's the good of FDA approval if you can't manufacture the product. It's all about the EDEN, until it's available there is no facility the company has, or contracts for, that can be inspected for commercial production, and that's part of the FDA approval process. The UK has permitted the manual facility at Sawston to meet their minimal requirements, that doesn't apply to the US and I believe the company knows that.

During the course of the trials, and beyond, the company has communicated with all the regulators, I believe they know what they must do prior to approval and they're in the process of doing it. If you cannot make the product commercially you cannot apply for it's approval.

Once again, it should be noted that Sawston is not adding tiny cleanrooms to expand manual production, they are adding large cleanrooms intended for EDEN production, I would think that should be telling investors how soon they expect the EDEN to be available to them.

Gary

[meirluc]

JT - Applying first to the FDA would have been much riskier because
the FDA has been a prisoner of BP whose interest is to destroy any
effective competition (e.g. DCVax-L) whereas the impartiality of the
MHRA is much more solid. Furthermore, NWBO has not yet validated
its automatic vaccine manufacturing methodology (EDEN-Flaskworks) but
its manual artisan method can supply some of the demand in a smaller
market like the UK. Therefore a BLA sent to the FDA would have had to
wait until the automatic EDEN methodology is ready to roll.

Once MHRA approval has been obtained and DCVax-L has been
demonstrating its efficacy, the FDA will not have the luxury of being
swayed by hostile interests and approval is almost assured, providing
that the USA demand for the vaccine can be met.