Separating fact from fiction. Please bashers, all of you can leave now. We are sick of you. If you don't like HEB -GO TO ANOTHER BOARD. Stop wasting your time and our time and just leave.
Wow, you are as dumb as you look sunshine if you believe this POS is going anywhere! I will be back to visit you morons from time to time this week to check and see how much money you have lost.
HEB NDA PUBLIC SERVICE FILING GUIDANCE (Part 1)
HEB NDA Filing Guidance – 2004
Assuming the results are positive, we expect to finalize the data of our double-blind, placebo controlled AMP516 ME/CFC Phase III clinical trial and submit an NDA by year end 2004.
HEB NDA Filing Guidance 2005 –Early 2006
The single shortfall of our 2005 objectives was the delay in the filing of our NDA for Ampligen(R) for the treatment of CFS. Our targeted filing by 2005 year-end was based on an anticipated grant of FDA permission to submit a rolling or staged NDA application, which would allow us to file the safety and clinical sections of the NDA application in advance of the manufacturing section. Even though FDA permission to submit a rolling or staged NDA application has yet to be received, since we are scheduled to complete our manufacturing certifications late in the 2nd quarter of 2006, we should, in any event, file our NDA for Ampligen(R) for the treatment of CFS no later than the first part of the 3rd quarter of 2006.
HEB NDA Guidance November 7, 2006
The year-over-year increase in loss of $1,164,000, primarily reflected a combination of factors including 1) an increase of $215,000 in manufacturing costs, especially in connection with a production ramp-up and the preparation of an NDA filing for the Company's experimental drug Ampligen(R) to treat Chronic Fatigue Syndrome, with that filing expected by the end of this calendar year or the first quarter of calendar 2007
HEB 10-Q November 7, 2006
We continue our efforts with respect to preparing a New Drug Application ("NDA") for submission to the Food and Drug Administration ("FDA") for using Ampligen(R) to treat patients afflicted with Chronic Fatigue Syndrome ("CFS"). The preparation of the NDA is a time consuming and laborious process….. We have experienced technical teams assigned to preparing each of these three segments. When completed these three technical documents will be consolidated into the common technical document for submitting to the FDA. While the results of our AMP 516 Phase III clinical study is the basis for filing the NDA we must also include the safety data collected on all patients that ever received Ampligen(R) (some 800 patients from clinical trials for CFS, HIV, Hepatitis, cancer, etc.) All of this is time consuming as our clinical monitors and research assistants must visit and audit the records of clinical investigators involved in our Ampligen clinical studies conducted over the last 15 years.
Note: On November 6, 2007, Dr. Carter was awarded a pay raise retroactive to January 1, 2006.
CONFERENCE CALL November 15, 2006
HEB filing to be INITIATED by December 31, 2006.
HEB Investor E-mail Re: BOENNING & SCATTERGOOD.INC Initial Coverage (12/4/2006) - We anticipate an NDA filing no latter than the first quarter of 2007. (Spelling error in press release.)
Note: Web site says NDA filing will be SOON!
HEB NDA PUBLIC SERVICE FILING GUIDANCE (Part 2)
Roth Conference in Dana Point – February 22, 2007 – Dr. Carter Presentation
The filing of the NDA will be completed by the end of the first quarter of 2007. Acceptance of the NDA filing is expected by the end of the second quarter of 2007.
March 19, 2007 10-K Filing
The NDA is being filed electronically to facilitate the ease of review by the FDA. We cannot yet provide guidance as to the tentative date at which the compilation and filing of the NDA will be complete, as significant factors are outside our control including, without limitation, the ability and willingness of the independent clinical investigators to complete the requisite reports at an acceptable regulatory standard, the ability to collect overseas generated data, and the ability of Hollister-Stier facilities to interface with our own New Brunswick staff/facilities to meet the manufacturing regulatory standards. However, the overall process is proceeding. We started the NDA registration process on December 29, 2006 with the filing of one of the three major required sections. The timing of the FDA review process of the NDA is subject to the control of the FDA and could result in one of the following events; 1) approval to market Ampligen® for use in treating ME/CFS patients, 2) require more research, development, and clinical work, 3) approval to market as well as conduct more testing, or 4) reject our NDA application. Given these variables, we are unable to project when material net cash inflows are expected to commence from the sale of Ampligen®.
PHILADELPHIA BUSINESS JOURNAL - March 30, 2007 by John George, Staff Writer
Hemispherx BioPharma Inc. is finalizing its new drug application for Ampligen, an experimental treatment for chronic fatigue syndrome that has spent more than 30 years in clinical studies.
Dr. William Carter, the Center City biotechnology company's chairman and CEO, said he expects the application will be completed in early April.
HEB CONFERENCE CALL – May 1, 2007
Dr. Carter says that HEB is working with the FDA to answer questions regarding the filing. He states the filing is complex and cannot give a timetable as to when the NDA will be filed.