Thx for all your responses.
If this would have been pivotal, it should have been determined upfront with the authorities. Pity that they did not try to go down that road. As is the case for some phase II trials (see bladder cancer trial of theralase). In their case they can commercialize after that trial if the results are good.
So yes also agree that a phase III is most likely to follow.
let's hope our management then utilize all opportunities to try to expedite it and to agree on milestones that could lead to earlier approval.
Thx for all your responses.If this would have been pivotal, it...
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