If they felt the data may be questionable in getting the HIV hold lifted, I don't think they would have withdrawn the BLA first because that would have been a big red flag for the FDA when considering removal of the hold. Don't forget the BLA needs to show safety first, and then efficacy. I believe it's the efficacy data that was lacking in the BLA. And they also have a significant amount of safety data from the patients who participated in other trials, I believe over a 1,000 when you include others who have taken LL. As I recall, I think the BLA submission was based on what, 40 patients? They have what they need for submitting the required safety data to have the hold removed.

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So far in my 6 years, when “The company believes…” something, it hasn’t worked out well for me. But I hope your right.

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