Yes they will speak to then about the formulation of a trail and the end points. It should not be a rationale for delay of the IDE. Very different to an IDE application.
FDA 'An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.'
Just for the record. 'End points can vary from overall survival to tumour shrinkage. The latter is what SRX went after and is what OSL is going after.'
If you refer to the SIRFLOX trial the primary endpoint was overall PFS, not tumor shrinkage. Liver was a secondary end point, as as you may well know it is being combined with 2 other trials to obtain OS data on ~1000 pts. The oncologists want to see these sorts of numbers, and indeed if you scan the trail databases you will see that 300-1000 is the norm in trials concerning cancer.
OSL may indeed become a great success but it is a very long and difficult, at times, road to travel.
OSL Price at posting:
23.0¢ Sentiment: None Disclosure: Not Held
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