DEP always first, page-8

I believe the timing of the meeting won’t have much bearing on the outcome, as FDA have been clear they want another trial, and SPL will be going into the meeting fighting an uphill battle. Even the most loyal supporters concede that “confirmatory data” is FDA speak for another trial.

The likelihood is that SPL probably won’t get a straight answer in the meeting, and management will need to make a judgement call.

a) Take a risk and resubmit the NDA with the same trial data they believe may address the FDA’s concerns and risk another CRL and lengthy delay; or

b) Be prudent and just run another trial that will 100% meet the FDA’s requirements and guarantee an outcome with the next NDA.

I’d be highly surprised and sceptical if SPL management came out and said it was all good to go, because that is not how the FDA works.

The FDA has a reputation as the toughest pharma regulator in the world for a reason, and they don’t play around with ifs or maybes... they ask for something and they expect a response that clearly meets their requirement.

I eluded to this a couple of times already, but the fact the FDA BV approval requirements are still in draft will give the FDA a lot of room to ask for something “left field” that SPL had not considered when running their phase 3 trials.