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anders2211

10/17/20 12:10 PM

#319183 RE: Veritas #319164


Let's say that TLD is solid, but not spectacular...

(1) what are the chances that the FDA does not approve
(2) what would happen to the share price if the FDA does not approve, even if trial data shows that efficacy for the treatment is solid?
(3) what are the chances that FDA does NOT approve, but it is approved elsewhere in Europe?



IMO:

1) since DCVAX has proven to be safe but only shows little stat efficiency in reference to SOC (Novocure for one). I still believe it will be approved. The question is then, however, in that case, if DCVAX will have a better marketing position towards its competitors.

IMO the rick NWBO for FDA rejection lies much more in the DCVAX production facilities being in the eyes of the FDA in order or not.
We all remember not only DNDD but also recently I forget the name darn another IMMU therapy first approved then after that rejected by the FDA for not having its immu production in order. anyone what was the name of that immu biotech?

2) If the FDA does not approve and EMA (German PEI) approves, the SP will more then half. A nice example is Dutch Galapagos. Beginning this year at Euro 225, EMA approved FDA rejected, SP tumbled to Euro 105

3) Well studies I read showed that the EMA is LESS strict towards drug approval than the FDA. IMO that change is highly unlikely but that is my investment thesis. I am 90% confident both will approve