big partnering deal imminent, page-25

I don't think PHE is saying AVX have to take a partner to the FDA with them as some sort of regulatory requirement. He's saying (correct me if I'm wrong here PHE) that they will want to go to the FDA with a partner in hand because they don't have the dollars to complete all necessary trials themselves AND any partner they engage with will want to have some input into how the drug is to be targeted and that will have a major bearing on the type of trials that should and should not be conducted. They may well talk to the FDA to get an idea of what each party is thinking etc, but nothing major and definitive should be expected until after the partner is signed up - unless it is a trial requirement that will apply regardless of how the drug is to be marketed and developed.

As an example of why a partner might influence those things - one company might want to have ATC approved as a front line treatment, others might not. One company might want ATC tested alongside certain drugs (their own for instance), others might want to use it as part of a different regimen. The trials leading up to such approvals obviously cover different patient groups. I wouldnt be too concerned...... as PHE and worthind have alluded to, the people at AVX seem pretty comfortable with how things are going, and that seems like a good reason to be quietly confident.