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Re: smallinvestor post# 4869

Friday, 03/09/2007 8:21:51 AM

Friday, March 09, 2007 8:21:51 AM

Post# of 6489
"are those studies real Phase II or not???"

Yes, the studies are Phase II in that they are not Phase I or Phase III. However, they do not meet the criteria for a FDA approved Phase II that could enable a Phase III if successful. That doesn't mean they are a waste. They will probably provide data to assist Insmed in designing a "qualified" Phase II ... and I think they may provide data that will allow a combination Phase II/III. That will be up to the FDA.

That probably added to your confusion, but there are simply Phase II studies, and there are Phase II studies. An analogy might be a house that was built to FHA specifications and a house that was not. They are both houses, and both may be quality houses, but one will not qualify for a FHA loan.
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