PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[oldberkeley]

From the PLX CC:

General request for additional data that PLX already has; no additional clinical trials. "It's a matter of processing the data that is already available, we don't think that this is gong to be a very long process."

Will meet with FDA to clarify what additional data is necessary.

After meeting they'll know if Class I (2 months) or Class II (6 months) review.

Almost as an aside, said quickly, that they were surprised that the FDA didn't ask for this info during the review process (never a good idea to get hostile & confrontational with the FDA, doesn't help.)

Often interpreting tone-of-voice stuff is inaccurate & silly, but in this case, it was pretty hard to miss both a disappointed and a somewhat disgusted tone, IMO regarding the above statement, why wasn't this additional data requested earlier.