Adcom = Advisory Committee
An Advisory Committee is relevant to companies within the biotechnology/pharmaceutical space. For those that don’t know the process of taking drugs to market, it can generally be broken down into stages. First is the preclinical phase, which typically involves the discovery of a promising agent and testing it on live animals (usually rodents). The results of In Vivo Testing are used to demonstrate the safety of the proposed drug in the Investigational New Drug (IND) application that is filed with the Food and Drug Administration (FDA). If the FDA approves the application, the stage is set for phase 1 clinical trials.
As the safety and effectiveness of the drug are tested and proven in humans, the drug can potentially progress from phase 1 to phase 2 and phase 3. If the drug is found to be ineffective, unsafe, or have intolerable side effects at any point throughout these phases, it can be discontinued. If a drug survives phase 1, 2 & 3 clinical trials, then a New Drug Application (NDA) is submitted to the FDA. Upon receipt of the NDA, the FDA completes an independent review and makes any necessary recommendations. This is where an Advisory Committee (Adcom) can come into play, which involves a panel of experts coming together at the FDA’s request to review various aspects of the drug, including (but not limited to) the trial results. Ultimately, the FDA has the final say in approval or rejection.
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