Hemispherx Biopharma (HEB) Reports a Q3 Loss; Comments on FDA Responses
Hemispherx Biopharma, Inc. (NYSE Amex: HEB) reports a Q3 loss of $0.02, 1 cent better than estimates.
On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).
The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.
[SM]
On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).
The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.
[SM]
You May Also Be Interested In
- UPDATE: Bristow Group (BRS) Reports Better-Than-Expected Q4 Results; Offers FY13 Outlook
- Mentor Graphics Corp (MENT) Beats Q1 EPS View by 5c; Lifts FY13 Outlook
- Hewlett-Packard Company (HPQ) Tops Q2 EPS by 7c; Guides Q3 Below the Street, Raises FY12 Outlook
Create E-mail Alert Related Categories
Earnings, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
