Trying to understand timeframe...Quickly gathered info. Hopefully accurate. Hopefully helpful for others: New Drug Application (NDA)/ Biologics License Application (BLA) If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated. • At the time of application Priority Review can be granted to drugs that treat an unmet medical need. • Orphan Drug Status is granted to drugs that treat rare diseases, or diseases that have no other available treatments. https://www.fiercebiotech.com/topics/fda_approval_process.asp • Corporate News Release • Bioniche Provides Corporate Update • 03/06/14 • Urocidin Regulatory Update • Bioniche is in active dialogue, with the US FDA concerning the most appropriate and efficient regulatory pathway for Urocidin in the Unites States. Bioniche expects to be able to report on the results of this dialogue prior to the end of June. Clarity on this issue is critical as it is a prerequisite for the company to increase its active dialogue with interested strategic parties. The company has also decided to re-apply for Orphan Drug designation in the Unites States. https://www.bioniche.com/news_item.cfm?id=2354 Accelerating US Regulatory Approval for Drugs and Biologics that Treat Serious Diseases What you really need to know about FDA’s Fast Track, Accelerated Approval, and Priority Review designations. Excerpt: Priority Review Timelines FDA has committed to reviewing and acting on: 1) 90% of NDAs/BLAs with a Standard Review designation within 10 months of receiving a complete submission. 2) 90% of NDAs/BLAs with a Priority Review designation within 6 months of receiving a complete submission. https://resources.rhoworld.com/Portals/161293/docs/Accelerated_Approvals_FINAL.pdf Easy to read (for a white paper) and with helpful visuals of process. https://resources.rhoworld.com/Portals/161293/docs/Accelerated_Approvals_FINAL.pdf Thank you to BNC for delivering this key step. Hopefully hear about Orphan Drug designation submission sooner-than-later. All the best, rg