Innovation Pharmaceuticals Inc (IPIX)

[FarmaZutical]

The PDUFA goals for special protocol assessment and agreement provide that, upon request, FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements.

But hey, does it really matter if the Ph3 starts in April or May ? What's important is that the company chose to engage in SAP guidance which is voluntary and that this interaction with the FDA usually leads to a more robust trail with even better chances of approval once the NDA is submitted. Very prudent step by management.