All possible Cato however 50 million is not that large as a starting investment . My feeling is that Novartis would be more concerned about the impact of our P3 on the way going forward . This may - will change some of the milestone payments. Novartis would have signed the deal knowing that the current trial may have down side but to protect themselves we see the term "may receive milestones up to..." For them to pay up now would I suspect rule out the possibility of changing the milestones at a later date due to the recent outcome.
So I think we are waiting for some guidance from the FDA going forward. How they interpret the results will have a impact on the milestones . They may well say that the trial was successful in the under 65s and is considered a successful P3 for this group , This would have a modest impact on milestones.
They could also say that despite some very interesting results we can only consider this trial as a P2 meaning that Novartis would need to perform 2 P3 trials before they would accept a BLA. This would have a significant impact on milestones.
The above possible outcomes do not release Novartis
from the original contract , perhaps there is something but it will not be any thing to do with the FDA and we haven't been told no, in any case why would they want to leave , the results are outstanding.
Good luck
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