"Exactly my point. The review of an off-the-shelf tablet should be easier to review, than a cellular based treatment coupled with GMP standards to consider"
I lost you here. While the composition of tablets used for treatments are much
more uniform and standardized when compared to the artisan produced DCVax-L
vaccine (which also varied with respect to the number of doses administered per
patient), the time it takes for the regulator to review the results is what is important.
I do not believe that a review of a trial demonstrating[ the efficacy of a not perfectly
uniform vaccine that also varies in the number of doses dispensed per patient, should take
much longer than the review of a trial that demonstrates the efficacy of a uniform
standardized tablet.
I admit that with respect to GMP standards, the lack of uniformity of the artisan produced
vaccine and the variation of doses per patient, do constitute a dilemma but hey, it is what
it is and THE OUTSTANDING RESULTS SPEAK FOR THEMSELVES..
Bullish
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