I think it is a little murky Sector. The P3 CLBP trial started...

I think it is a little murky Sector.

The P3 CLBP trial started with the composite primary outcome for pain and function with no post treatment intervention to be assessed at 12 months.

The agreement with Grünenthal was for them to fund MSB to the tune of $15m to conduct a parallel trial to support European approval – if MSBs trial met its primary endpoint.

The totality of the evidence from both trials would be used to support approval in both jurisdictions.

Unfortunately, MSB had failed to get the green light from the FDA about this design and the endpoint was changed from 1 year to 2 years after the trial had begun.

As we know the P3 CLBP failed and Grünenthal pulled the pin on the $15m to fund the second European trial.

Which gets you to where we are today … the CR at 75c to start a second P3 CLBP trial. This wasn’t Pl an A.

In terms of timelines:

The P3 CLBP trial with the main outcome assessed at 2 years took around 5 years to complete (from the date of registration to final results).

The proposed P3 CLBP trial will have the main outcome assessed at 1 year. This leads to the proposed P3 trial being quicker than the first P3 trial because the follow-up period is shorter and the trial is smaller in size because the attrition rate will be lower.

On the other hand of the 500 steps required to implement a clinical trial COVID is impacting on virtually all of them. So 3-4 years to complete the next P3 CLBP trial – with results perhaps 2026.