I would have expected the granting of a FDA IND to be direct...

I would have expected the granting of a FDA IND to be direct company announcement rather than a trading halt. I’m anticipating that this will not be positive news unfortunately.

We always planned to open an IND due to US sites, we just wouldn’t have had capacity to successfully file a NDA due to not complying with the FDA’s request for two trials powered for PMD.

My suspicion is that the FDA has come back to Invex with additional modifications they wish to see before agreeing to an IND.

Depending on the changes suggested, they will either be possible or not, with the material downside being that Invex’s Phase III proceeds with their global trial without FDA IND and US trial sites. A trial without US sites is always harder to get an NDA through the FDA.

On Monday, I expect they will get the update along with an investor call from Tom Duthy summarising the feedback alongside Invex promising to consult with their advisors on the next steps with the FDA.