Bioequivalence and Bioavailability Forum

Hi Captain,

❝ This is all about what Sponsors should do in this situation.

❝ Now, where's information on what regulators should do?

Very clever, you have turned the arrow!!! You are right, I totally agree with you, the jurisdictions bodies should circulate informations, assessment principles & rules how they will treated the conducted and submitted Clinical trials in Coronavirus situations.

❝ A negative scenario is if a trial is so affected by the Corona virus situation that regulators after submission will not be able to use the data to form a qualified decision whether positive or negative. In such cases, in hindsight, the trial should have been terminated for futulity.

Again, I agree with you.

❝ Therefore, I consider it of importance that we hear from regulators not just what they think Sponsors should do, but also what they think they should do.

I think you hope too much regarding this point. As I know, regulators prefer freezing all submissions in this time, let's wait and drink tea.