Ann: Invex Granted Type C Meeting with FDA, page-21

To be honest, the formulation and contract manufacturer isn't the main show - I'm waiting with bated breath on the FDA advice on one vs. two studies.

Other ASX companies are getting Pre-IND meetings with the FDA like $IHL, so it's disappointing to see Invex only receiving written advice rather than an actual teleconference.

Invex needed the teleconference to prosecute the argument for one trial, however having this discussion in written format I worry that it's a lot easier for the FDA to revert back to their previous advice of two well-controlled studies. Only Mid-June will tell!