Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

I was responding to a poster who asked "Wonder if that time is sped up with the QIDP?"

...about this....

"From FDA website on SPA...
A. Timing of Request
"...generally recommend that a sponsor submit a protocol intended for special protocol assessment to the Agency at least 90 days prior to the anticipated start of the study."


....and I'm fairly sure I was correct in saying that the QIDP doesn't come into play at this stage.
I know that the company is also eligible for Fast Track and Priority Review under QIDP but I don't know if they have applied for same. Do you?

I believe that the Priority Review is of the NDA whereas the Fast Track would effect the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval.
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers.

I'm under the impression that none of these programs, even if in place, would have any effect on the "90 days prior to the anticipated start of the study" FDA recommendation.