FDA ODAC Meeting Material discussion analysis, page-368

Hi Stockrock – I think you are getting a little bit of the wrong end of the stick here.

It is kind of correct to say as you do that the FDA don’t believe the trial was well designed. And that they have rejected MBS arguments in their submission.

But we should express this a little more precisely - carefully.

The FDA, and to be more specific, the FDA review team, have formed an preliminary opinion (expressed in their briefing document) that the trial was not well designed.

But the FDA have uncertainty around this preliminary opinion.

In order to help resolve the uncertainty prior to making a decision they have decided to hold an AdCom meeting with specialist experts.

The FDA are very open to being persuaded that their preliminary opinion is wrong. They have genuine uncertainty. And you only have to look at the issues to see that they are complex and very subtle; not clear cut.