The issue is that the FDA provides guidance. They don't tell you what you can and can't do. The point being they aren't going to give you the answers you seek. They are going to say well you could do that and this is probably what we would look for in that instance.
Avexa could go for a special protocol assessment (SPA) in which the FDA agrees on trial design and outcome measures before the trial begins, which would add some certainty to the regulatory route, but when it comes to SPAs the FDA is fairly conservative because they can't come back at the company later if something goes wrong. The point being that with an SPA the regulatory bar is likely to be higher and consequently costs are likely to be higher as well.
We know that Avexa has been in contact with the FDA and that the FDA indicated they needed to change their phase III strategy (this was a while ago). So to say that Avexa has not been receiving guidance from the FDA to me is wrong.
Also, the major issue Avexa has is not the FDA, it is that they lack the cash (in any form)to complete the pivotal trials required. Changing the indication is highly unlikely to change the cost of the pivotal trials required in any substantive way and unlikely to change the view of prospective partners.
The only hope that I see for Avexa re ATC is that they could find an orphan indication for which ATC may be useful. It is substantially cheaper to bring orphan drugs to market. From talking to management late last year, I was under the impression that part of the reason for stopping the current trial early was so that they could troll through the data in the hope of finding such an indication. An orphan indication would also get them around their ATC patent issues, at least for seven years.
I don't know whether or not they found such an indication, but it is clear that whatever they found was not enough to convince prospective partners and, for the above reasons,I can't see why further consultations with the FDA are going to help.
Cheers,
Bob
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