FDA Rejects ADMA's BIVIGAM Drug Substance But Approves Drug Product? [Seeking Alpha]
ADMA Biologics Inc (ADMA)
Last adma biologics inc earnings: 3/12 04:05 pm
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US:NASDAQ Investor Relations:
ir.admabiologics.com
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Source: Seeking Alpha
On December 19th, ADMA Biologics ( ADMA ) received a complete response letter (CRL) from the FDA in regards to the Prior Approval Submission (PAS) for their intravenous human immunoglobulin (IVIG) product, BIVIGAM. This came as surprise to investors due to the company receiving an improved compliance status at their manufacturing facility for BIVIGAM in September. According to the company press release, the CRL mentioned issues with BIVIGAM’s chemistry, manufacturing, and controls (CMC) data. However, it did not request supplementary information on compliance status, safety, efficacy or any additional info on third-party contract manufacturers or vendors. Additionally, the CRL did not have any demands for additional manufacturing runs. What is more, the company received PAS approval for the drug product, but not for the drug substance. This left me with more questions than answers, but thankfully the company hosted a conference call covering the CRL and the company outlook
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ADMA
Earnings
- 2/28/24 - Miss
ADMA
Sec Filings
- 4/15/24 - Form ARS
- 4/15/24 - Form DEFA14A
- 4/15/24 - Form DEF
- ADMA's page on the SEC website