Adverum (NASDAQ:ADVM) announced that one of its gene therapy products, known as ADVM-022, was placed on a clinical hold. It was just an issue the FDA had with CMC data. This, in essence, deals with the FDA needing additional information for manufacturing and processing of the gene therapy ADVM-022 to treat patients with wet age-related macular degeneration (Wet-AMD). This shouldn't be a major issue and I believe in the coming weeks Adverum will get the green light to continue its program. Investors can greatly benefit from an upcoming catalyst of phase 1 results in the second half of 2019.
FDA Clinical Hold
The FDA clinical hold of the phase 1 OPTIC study is only a temporary minor issue. That's because the FDA only needs to review additional CMC data. Adverum received the notice of a clinical hold for this study in early April. However, it had already submitted its response to the FDA last week. What that means is that I expect the FDA to lift the clinical hold in the coming weeks. In my opinion, I don't see ADVM-022 as being toxic for any patient. I think it's just the FDA being cautious about the manufacturing process. For example, one can look to the recent advancement of ADVM-022 to see that the drug is safe to take. The first cohort of this phase 1 study, dealing with 6 patients, was already completed. An Independent Data Monitoring Committee (IDMC) already stated that there were no serious adverse events or dose limiting toxicities observed with only one injection of ADVM-022. What that means is that it got the green light by the IDMC to advance to the second cohort. All that awaits now is the FDA decision to allow the study to resume. I believe that this should happen in the coming weeks. If the FDA removes the clinical hold that will likely act as a positive catalyst for the stock. However, there
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