Edski1,
the interesting thing for IPPS is:
1. We have good efficacy
2. We have good safety
3. There is a massive umet need
4. It works very well
IPPS is not line ball proposition. Our results have not been mixed they have been excellent on a number of fronts. I think once we get the back and forth with the FDA on the IND out of the way it will be predominantly positive from there. As someone said in here previously, OA is a big market so the FDA are going to scrutinise accordingly. With continued good results and no AE's we may get a police escort instead of another speeding ticket.
The Pool
ps the great risk I see at the moment is COVID. Its bubbling away in the states and it has the potential to derail our timeframes yet again. It may push the timeline out further due to pressure on FDA resources and getting trial participants through the program etc.
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