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Monday, August 05, 2019 6:58:08 AM
No mention of Mono therapy trial start. It means it is not happening this year
Rather, it means that you cannot read properly.
“Our goal firmly remains to complete in September 2019 the BLA filing with the FDA for leronlimab as a combination therapy with HAART for HIV-infected patients and hopefully initiate our first monotherapy pivotal trial for label expansion soon after our in-person meeting with the FDA,” continued Dr. Pourhassan.
The FDA meeting is around 20th of September, and if they reach an agreement about the protocol, the trial can be initiated thereafter.
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