Blafarm - this is not the case for CYDY due the nature of the RTF. The “restarting “ of the clock is dependent on the nature of the RTF. The FDA filed due lack of information, not flaw in the BLA construct. Once they have the requested information, and if the issue is resolved by CYTODYN’s answers, then the filing will proceed on schedule from - THE ORIGINAL TIMELINE. Critical to this answer was 700mg dosing safety which came from the interim M/M trial “safety review.” The needle issue can be easily assuaged by simply removing the needles from packaged products or using needle packaging already approved for other drugs. The former is more likely in that case, imo. You will hence have to go to a clinic to have the dosing administered - not optimal for marketing the simplicity of using the drug, but it expedites the approval..