Innovation Pharmaceuticals Inc (IPIX)

[Waverunner1]

I'm not giving a definition of anything, I am describing the process. A Fast Track designation is not something that is automatically bestowed on a company by the FDA, it must be requested by the company at a time they feel is appropriate. CTIX has elected to wait until the Phase 3 trial sites are set up. Because of the QIDP it should be pretty much a lock.

Not sure your definition of fast track is correct. See below - fast track is granted even in phase II and supposed to be given for treatments for unmet demand - B may not fall into this category as there are many ABSSI treatments.

"Merck KGaA MKGAF and partner Pfizer Inc. PFE announced that avelumab received fast track status from the FDA for the treatment of metastatic merkel cell carcinoma (MCC). The candidate is being evaluated in a phase II study, JAVELIN Merkel 200, for this indication.

The FDA usually grants fast track status to candidates that are being developed as potential treatments for serious conditions and are considered to be capable of addressing an unmet medical need. "