Replies to post #24587 on 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

[DewDiligence]

>[GTCB] This issue, the difference in the dosing was in the first submission. So what was the 2 years consideration including 2 delays about?<

Beachgal et al: the CHMP (the decision-making body) does not get involved in the approval process until the EMEA staff has completed its review. I.e., it’s the EMEA staff that considered the ATryn application for two years, and the CHMP examined the application for the first time this week.

Traditionally, when the EMEA staff intends to make a negative recommendation to the CHMP, they request the applicant to withdraw the application, but that didn’t happen in this case. The probable reason: the EMEA staff was not clearly negative on the dosing issue nor on the application in general. The EMEA staff may have been split on the dosing issue and the other issues.

It’s easy for people to say that the whole two-year review process was BS and the application never had a chance to be approved for political reasons. I respectfully disagree. With more patients and no alteration in the dosing protocol, I think the application would have breezed through, politics and all.

This is not to say that the EMEA approval process works well—it clearly doesn’t. No applicant should be jerked around by regulators for two years and then be presented with Catch-22 explanations for refusal. However, saying that the approval process has major shortcomings is a far cry from saying that it’s an outright sham.

Exclaiming that the ATryn decision was about nothing but politics is a bit like complaining that, when your stock goes down on no news, it must be due to manipulation. It’s an easy way out, but it’s intellectually dishonest in my opinion. Regards, Dew