HEB - Hemispherx BioPharma

[Sarkhan]

Wow no one has brought HEB back up in a while.

Now, I am just speculating, I dont know how the FDA works exactly, this is just from past experiences that I have seen from other Drug companies in regards with the FDA.

So on December 1st 2009, HEB released stating that they received a Complete Response Letter. When exactly they received it is not known and that was the reason for the lawsuits thrown at HEB for "hiding information".

Using the date December 1, 2009 as the date of the 'Complete Response Letter', from what I have seen with other Drug companies after receiving the CPL, that they are up for a review either 3 to 6 months from the CPL date. So It has been 3 full months and a half. Does anyone know exactly when HEB will be up for another look? I have a feeling it will be May, but I am not sure, as the days go and the stock stays steady, I cant wait for HEB Part 2 to unfold.

Since the CPL, HEB has released many good news regarding Ampligen, may even be time for its approval. The days of low 60 cents seem to be behind, it rose to above 80 cents a few days back, sitting in the 70s now. If you are thinking of getting in on this stock, now is the time, the price is tremendous, the growth will be even greater.

Please help me out and post here if anyone understands exactly how CPL works and when exactly they are due for a another look.

[bdogsdad]

I don't remember exactly but I thought the FDA told HEB to run anther clinical trial of at least 6 months due to the fact the FDA could not find any benefit from patients taking ampligen in the previous study. I will go back in my archives and see if I can find the PR describing the letter. I would also look into re investing in HEB.

[marketwatch]

You can't trust Dr.Carter and HEB. Besides that, the FDA has asked for a lot more data (see below).


the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.

Other items required by the FDA include certain aspects of Non-Clinical safety assessment, and Product Quality. In the Non-Clinical area, the FDA is recommending that the Company complete rodent carcinogenicity studies in two species. As part of the NDA submission, the Company had requested that these studies be waived, but the waiver has not been granted. Certain additional non-clinical studies and additional data to support non-clinical studies already submitted with the NDA are also recommended by the FDA. Prior to the receipt of the Complete Response letter, the Company had already begun many of these additional studies and the collection of the requested additional data.

Under the Product Quality section of the Complete Response letter, the FDA recommends that the Company submit additional data and complete various analytical procedures. The collection of these data and the completion of these procedures is already part of the Company's ongoing Quality Control, Quality Assurance program for Ampligen manufacturing under cGMP (current Good Manufacturing Practice Guidelines) and the manufacturing enhancement program recently undertaken by the Company and announced in a news release on September 16, 2009.

Finally, the FDA commented on Ampligen manufacturing noting the need to resolve outstanding inspection issues at the facilities producing Ampligen. These include the Company facility located in New Brunswick, NJ and one of the Company's third party manufacturing facilities (Hollister-Stier Laboratories). The Company has been working to resolve these issues

StreetInsider.com - Hemispherx Biopharma (HEB) Receives Letter for Ampligen From US FDA; FDA Cannot Approve Application in Present Form

[bdogsdad]

Yep, that's the one I remembered reading. Thanks for the post. I agree, I believe this can be bought below .40

[pcstock]

You can't trust Dr.Carter and HEB. Besides that, the FDA has asked for a lot more data (see below).


the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.

Other items required by the FDA include certain aspects of Non-Clinical safety assessment, and Product Quality. In the Non-Clinical area, the FDA is recommending that the Company complete rodent carcinogenicity studies in two species. As part of the NDA submission, the Company had requested that these studies be waived, but the waiver has not been granted. Certain additional non-clinical studies and additional data to support non-clinical studies already submitted with the NDA are also recommended by the FDA. Prior to the receipt of the Complete Response letter, the Company had already begun many of these additional studies and the collection of the requested additional data.

Under the Product Quality section of the Complete Response letter, the FDA recommends that the Company submit additional data and complete various analytical procedures. The collection of these data and the completion of these procedures is already part of the Company's ongoing Quality Control, Quality Assurance program for Ampligen manufacturing under cGMP (current Good Manufacturing Practice Guidelines) and the manufacturing enhancement program recently undertaken by the Company and announced in a news release on September 16, 2009.

Finally, the FDA commented on Ampligen manufacturing noting the need to resolve outstanding inspection issues at the facilities producing Ampligen. These include the Company facility located in New Brunswick, NJ and one of the Company's third party manufacturing facilities (Hollister-Stier Laboratories). The Company has been working to resolve these issues

StreetInsider.com - Hemispherx Biopharma (HEB) Receives Letter for Ampligen From US FDA; FDA Cannot Approve Application in Present Form

I think the issue on the manufacturing has been resolved: Hemispherx: FDA office says one Ampligen issue addressed - Philadelphia Business Journal:

Has HEB even talked about its plan to start the additional study required by FDA and to resolve other issues cited in the CRL?

[bdogsdad]

Not that I know of, they are still trying to convince the FDA to go with the data submitted in the original NDA as far as I know.