Why is the FDA taking so long?

On August 9th, the FDA completed their review of our IND and allowed the phase 1 human trial of our HIV cell therapy to proceed. Data is expected to be gathered and reported by AGT throughout 2021.

It is always somewhat unpredictable how long the FDA process will take at each stage of the human trial and approval process. Due to the breakthrough nature of gene and cell therapies, the FDA is overwhelmed with INDs and seems to be understaffed in gene and cell therapy experts to efficiently process applications. We understand your frustration over the delay, but the FDA exists for the safety of patients. Negotiations with the FDA may take time, but the result will hopefully be a well-tested treatment that we can confidently release to the public. There are many factors that are beyond our (and even the FDA's) control that may cause delays, but they are all important to consider in advancing medicine.

We ask for your patience, and also that you avoid posting messages to us that could be considered "political". We are purely a scientific organization, and we do not have the resources to consider and answer non-science or non-drug-development concerns or suggestions. Thank you for your support of AGT's mission and work. We hope that we can continue to have your support and goodwill in our ongoing efforts to make an important difference for HIV+ persons and at-risk communities.

Best regards,

- The AGT Team.