Biotech Values

[rph_in_wi]

RE: the approval process has major shortcomings

When evaluating what went wrong, who do you blame for this rejection?

GTCB's loose dosing protocol, if not discussed with the EMEA beforehand, would be an immediate red flag. In the CC GTCB sounded like the need for repeated dosing adjustment was unexpected and that they now have a standard protocol. Their inability to understand the need for a standardized protocol may be due to the EMEA guidance or their own inexperience. I do understand that lives were saved by this dosing, but it is no way to run a study.

THe EMEA casts great suspicion on their motivations by the inclusion of some very obvious straw men (ie: filtration and antigenicity)in their rejection notice. As already discussed, these worries are weak and act only to draw attention away from a problem with the study group. The 2 year delay only reinforces the perception of ulterier motives and casts doubt on the integrety of the organization. Whether it is a discomfort with goat-derived medicine or a conspiracy to aid Pharming, the conspiracy folks certainly have the fodder.

So who dropped the ball?

RPh