ATLnsider,
Serious public health risks is about the furthest problem being considered by MHRA. Even the one who shall not be named considered it a placebo since there were essentially no known risks other than minor very tolerable ones with this treatment. This point is the biggest reversal from the bear stance over time which of course implies that they look foolish trying to defend a non active treatment status for L directly so they do so indirectly hoping investors won’t notice.
Since the NIH’s problem with contamination of albumin, a necessary protein component of L, in their own lab from an open processing situation, regulators have wanted closed system manufacturing of cell products to safeguard against any possible contamination during cell treatment processing. NWBO needs this for their business model to work as well since L by itself is expensive and has more limited benefit on its own as tested in the Phase 3 than in a synergistic combo which makes allowable reimbursement rate a problem except for those likely to benefit the most. This is why the IFR reimbursement program is helpful by being able to select patients most likely to respond at a greater rate of benefit until NWBO can get the price they need down with Flaskworks which addresses all of the biggest concerns of regulators about potential safety issues during …manufacturing, manufacturing, manufacturing. Best wishes.
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