Bioequivalence and Bioavailability Forum

Dear ElMaestro!

First thank you very much for your example of childish and parental behaviour! Also your tractatus about random procedures was quite amusing.

❝ […] regulators (at least in principle, in Europe) do want to know about it AFAIK when you apply for a clinical trial in case an IEC/IRB has given thumbs down (H3 on the form).

Just for people not familiar with EudraCT: Section H of the application form (which has to be used in all EU members states) deals with the Ethics Committee:
H.3 Authorisation/opinion: [ ] H.3.1 to be requested [ ] H.3.2 pending [ ] H.3.3 given
If given, specify: H.3.3.1 Date of authorisation / opinion:
               [ ] H.3.3.2 authorisation accepted / opinion favourable:
               [ ] H.3.3.3 not accepted / not favourable.
               If not acceptable / not favourable, give:
               H.3.3.3.1 - the reasons
               H.3.3.3.2 - the eventual anticipated date of resubmission:

❝ So although you may not be breaking any laws […]

OK, I will speak from an Austrian perspective (but generally similiar procedures will apply in other member states). GCP regulations (Directive 2001/20/EC and follow-ups) are implemented in national laws (in Austria it's the 'Medicines Law' - Arzneimittelgesetz / AMG). If the EC has objections (AMG §41a/b), the sponsor may modify the protocol by an 'Substantial Amendment'. If the sponsor does not modify the protocol or the EC still has objections, the competent regulatory authority has to enjoin the study within 60 days after the first submission (AMG §40/4).
Theoretically the decision of the EC may be overulled (AMG §49) if the 'Advisory Board on Medicinal Products' - Arzneimittelbeirat (consisting of six expert members and optional additional experts) gives a positive vote.
I wrote theoretically, because the Advisory Board deals only with the very tricky questions (e.g., gene therapy) - if your BE study was rejected by an EC chances are practically nil.

❝ Come on, there must be others out there who have a much more qualified opinion about this interesting issue?!

I'm not qualified, but do know how to