Biotech Values

[rstor1]

gtcb

So what was the 2 years consideration including 2 delays about? The size of the surgical portion of the trial was known at first submission. None of this makes any sense.

There is no positive take on it. Either the EMEA is looking for any excuse to avoid dealing with an approval, or the company is completely out-of-touch with the regulators. This type of issue, if it is a real issue, should have come up much earlier in the process. Same thing for the immune response - one would think that somebody would have asked for guidance on what constitutes an acceptable number.

Regards,
Bob