MSB to dispute FDA finding in Type A meeting, page-87

Hi

The last formal meeting that I am aware of is the late-cycle meeting, which is before the ODAC. In some cases there is a meeting after the ODAC.. but it's not always the case. MSB indicated they were going to discuss the outcomes with the FDA after the ODAC, so I assume they did have a meeting post ODAC.

In terms of the Type A meeting, this is common after getting a CRL and the meeting is expected to occur within 30 days of the FDA receiving the meeting request. Not much more to add, and while MSB are confident of a positive outcome... all companies have to say that, and given how the FDA is clearly trying to make an example of MSB as the benchmark for approval... I don't think any of us can confidently say they know what the FDA is going to do from here on in.

When the FDA is willing to go against a 9-1 ODAC vote, with a paediatric popn with a disease with 80% mortality and no other approved treatment considered standard of care... it definitely defies logic and forces me to default to a very conservative view on when MSB will get approval.