Replies to post #26585 on Mymetics Corp (MYMX)

[Work Harder]

What is needed for an IND submission?

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated-products

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435682/

The IND must make a decision on your application for review within 6 weeks. The decision period of 6 weeks always starts on the last day on which you are able to submit an application for review. Even if you submit the application for review earlier. This decision period can be extended by a maximum of 6 weeks.

A Refresher on A/B Testing

https://hbr.org/2017/06/a-refresher-on-ab-testing