Bioequivalence and Bioavailability Forum

Suppose a company have conducted one pilot study to access the suitability of the test product for the further pivotal BE evaluation and fortunately results of this pilot study has passed as per the EU regulatory acceptance criteria of 80-125 for all the parameters including partial AUCs.

Does the EU Authority accept pilot study data with below mentioned loop holes for the registration of product?

1. This study lacks ISR
2. Do regulatory accept the ISR post statistic analysis?
3. The title of the study mention the word " Pilot study"

Does anybody have an example of such regulatory authority approval or comments for such kind of submission?

Awaited for your response.

Regards,
Kumar