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Monday, February 27, 2017 4:26:52 PM
Unidentified Analyst
Yes. Hello. I just have a quick question regarding P3 combo. I know we only have 12 enrolled and your anticipation as we can get the other 18 enrolled in Q1 along with primary efficacy point, which is the one we follow-up? Why are you so optimistic about getting 18 when it’s taken so long to get the first 12 of that in all respectfully? Thank you.
Nader Pourhassan
No. Very good question actually. Thank you. When we first started this trial we immediately stopped our processes as we were enrolling hospitals and then back to FDA and asked instead of having three drug resistance let us have two drug resistance, that process when you send a letter it takes 30 days waiting and then you get it and you have to train all the sites again. Then we went back to FDA say let us have one drug resistance and when you go through all of these processes it took us about a year, doing all of these and as we got where we need to get, which is reduce number, during this one year we enrolled 38 sites and hospitals.
Now if you check with any institute or any CRO, enrolling hospital, two or three per month or maybe four or five per month is a lot. So we were working on getting the hospital situated and now they are very excited and they are able to find the patient. And the fact that we have 13 patients in the screening and these 38 hospitals just need to give us one patient per hospital and that’s 38, not counting the 13 in the screening.
We talked to our senior clinical person and he is very optimistic that we can have this. Obviously, we are not saying that this is 100%. We need to see how it folds out. But it’s very positive and we went through Thanksgiving and Christmas and we still enrolled. So I think these numbers are very exciting and we are going to be able to have our primary endpoint first quarter as we have said before.
Link here: http://seekingalpha.com/article/4034678-cytodyns-cydy-ceo-nader-pourhassan-hosts-investment-community-conference-transcript?part=single
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