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H2R

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H2R

Re: wodehouse post# 2935

Sunday, 04/10/2016 10:49:19 AM

Sunday, April 10, 2016 10:49:19 AM

Post# of 3266
I went back to the Quarterly CC and was reminded of the time frames, which shows Ph 3 is quite some ways away. So the 8-K is very early in preparation so the cash is ready for Ph 3. Maybe the enrollment of Ph 2b is going well.

Or maybe the gestational age babies 29-32 weeks (which is supposed to be enrolled first) is showing great results.



Craig Fraser (Chief Executive Officer and President)

I’m happy to report we are on track with these trails and expect the 2a trail to complete mid-year and the 2b to complete enrollment by the year-end with topline results in the first quarter of 2017.



Then on the Q&A, Larry Smith (the one from SmithOnStocks) has a question about time frames:


Larry Smith

I got quick questions. One of them is assuming that the results in Phase 2b are positive I presume that you’ll have an end of Phase 2 meeting with the FDA and then proceed into Phase 3. Could you give us an idea under that particular scenario, when we might see completion of enrollment in Phase 3 trial and topline results?

Craig Fraser

Yes Steve feel free to comment, we – what you said with regard complete the Phase 2b obtain the answers that we’re looking for has an end of Phase 2b meeting with the regulatory authorities that is the plan. Right now it will be little bit premature to be able to accurately forecast all the way out to the end of Phase 3 because there’s still a lot of design answers to be gained and therefore designs to be constructed around what the Phase 3 program was made. So we really wouldn’t want to talk so early about it so specific until we have a few more answers.

Steve you have any?

Steve Simonson

I think that’s spot on and one of the main things that we need to find out in the 2b study is what kind of effect size we have and that will determine in large degree the size of our Phase 3 program. And so we are dependent on getting that data going forward.

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