In June 2017, ADMA acquired ownership and all rights to BIVIGAM® during the acquisition of Biotest's therapy business unit assets. BIVIGAM is a specialized biological product developed by ADMA Biologics, Inc. It is an intravenous immunoglobulin (IVIG) derived from plasma, used for treating immune deficiencies and preventing certain infectious diseases. Using ADMA's optimized IVIG manufacturing process, the FDA approved a Prior Approval Supplement (PAS) to modify the product's Biologics License Application (BLA) on July 26, 2018, allowing the company to resume supplying the drug to the U.S. market. A PAS submission is a regulatory filing submitted to the U.S. Food and Drug Administration (FDA) for an existing pharmaceutical product that has already been approved. It is used to request approval for modifications to the manufacturing process, formulation, labeling, or other aspects of the product that require FDA review and approval before implementation.
Unfortunately, initially, the FDA decided not to approve the PAS request for Bivigam, issuing a Complete Response Letter (CRL) to ADMA, similar to the one received by TRVN. The FDA's CRL pertained only to the drug substance PAS submission, focusing on chemistry, manufacturing, and controls information. ADMA believed that the FDA's comments were manageable and planned to request a meeting with the FDA to provide clarification and responses to the issues raised in the CRL. Just 2 weeks later, ADMA submitted all the necessary information required by the FDA.
In addition to Bivigam, ADMA sought approval for Asceniv, a brand name for an intravenous immunoglobulin (IGIV) solution developed by ADMA itself. It is indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years old). This condition involves a defect in the immune system, leading to an increased susceptibility to infections. Asceniv works by providing antibodies to help prevent infections in individuals with PI.
Facing the potential dual approval of Bivigam and Asceniv, my team and I wasted no time in buying shares. As expected, on May 10, 2019, 5 months after the CRL, the FDA approved the marketing of BIVIGAM. Subsequently, I engaged in some trading of the stock to make some profits. You will find a summary of the various purchases and sales across different accounts.
On account 3, I made a profit of $554.59. On account 1, I made a profit of $1960.65. However, on account 2, unfortunately, I incurred losses due to a last unfortunate trade, resulting in a deficit of -$1912.8.
Account 1
Account 2
Account 3
Overall Result : $602.34
Moral of the story: a single bad trade among several good ones can have a very negative impact on the return on investment. Greed and impatience do not mix well. The last losing trade resulting in approximately $3500 in losses was made knowingly. Typically, if there's another biotech stock that I absolutely want to own, I'm willing to sell at a loss to buy it quickly if the transaction seems reasonable. Currently (as of February 20, 2024), the price of ADMA stock is $5.28. Generally, the biotechs that my group of investors and I choose are often profitable if sold at the right time.
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