Jatter , in not sure about your assertions. For one thing the FDA is NOT WORKING WITH OSL, any more than any other company that seeks regulatory approval.
To imply otherwise is most misleading, put shows a fundamental error in how the FDA works. I know OSL would like retail punters to think this, but it is just not true.
Moving on to the trial. An IDE allows a business to conduct a trial. Generally a phase 2 trial would be conducted across a small number of centres, with probably 20-50 pts. This can and often odd painfully slow, and I'd expect this to take at least one year. Then the data has to be collated. If PFS in the pancreas odd the aim then the appropriate lengthy of time had to pass first. Then the data is sliced and diced by a clinical trials statistician, and then the data is presented. Should the data look promising, then plans are made for an aoplication for a PMA and a phase 3 trial, probably around 300+. This will almost certainly take 3 years by itself.
I would not worry too much about a take over in the near future. I think you will have plenty of time to ride this one.
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