Twitter

Link your Twitter Account to Market Wire News


When you linking your Twitter Account Market Wire News Trending Stocks news and your Portfolio Stocks News will automatically tweet from your Twitter account.


Be alerted of any news about your stocks and see what other stocks are trending.



home / news releases / ADMA - ADMA Biologics Investors Prepare For RI-002 PDUFA


ADMA - ADMA Biologics Investors Prepare For RI-002 PDUFA

Back on December 19th, ADMA Biologics (ADMA) received a complete response letter "CRL" from the FDA concerning their PAS for BIVIGAM. The FDA had provided an improved compliance status at BIVIGAM's manufacturing facility back in September and had already delayed the PDUFA date in order to review the company's submitted package. Moreover, the company received a PAS approval for the drug product, but not for the drug substance. The CRL was a shock to the company and investors because most signs pointed towards approval. ADMA's CEO Grossman believes "the FDA ran out of

Read more ...

Stock Information

Company Name: ADMA Biologics Inc
Stock Symbol: ADMA
Market: NASDAQ
Website: admabiologics.com

Menu

ADMA ADMA Quote ADMA Short ADMA News ADMA Articles ADMA Message Board
Get ADMA Alerts

News, Short Squeeze, Breakout and More Instantly...