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HEMISPHERX BIO
4.720 (c) USD
-7.45% 
valeur indicative 4.214 EUR

US42366C5094 HEB

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HEMISPHERX BIO : de Dianne

sevy00
22 oct. 201316:33

1è mail

Dear Dianne hello,

The 18/10 day of the meeting, President Carter he contemplates startling revelations and glad tidings for investors???

In my last email, the issue was the refusal of the FDA for approval of Ampligen.

The FDA requested additional Phase 3 trial. It is started??

President Carter hypothesized a call to the FDA. A he filed??

good to you

1è réponse


Dear sevy,

The annual meeting of stockholders was held today. This is simply a routine mater with nothing being discussed that is not in the public domain.

Dr. Carter stated at the Rodman conference that the company has not moved forward with the confirmatory Phase III trial requested by the FDA.

The company has not requested a formal “end of review” meeting, but Dr. Carter did state at the Rodman conference that there is dialogue with the FDA.

With kind regards,

Dianne

2è mail et REPONSE


Dear Dianne,

Thank you for your reply.

Automatic translation google n is not very clear. Can you say more (explanations on discussions with the FDA) of the third paragraph?

[Dianne Will] I know. But the translations are helpful.



Is it still possible that these discussions with the FDA could lead to approval of Ampligen?

[Dianne Will] I really do not know, nor has HEB expressed an opinion to me. I believe what was stated that there is dialogue (talk), but am not knowledgeable about what the discussions are. I personally think it would be unusual for the FDA to reverse itself, but the FDA did exactly twice last year that I know of with two diet products.


If Dr. Carter still he plans an appeal to the FDA or possibly a phase III?

[Dianne Will] The SEC filings state that the appeal would depend upon the outcome of the ?End of Review Meeting?. HEB will file the next 10Q on or before November 14th. We wil have to wait to see if there is updated information about Ampligen and CFS.



Best regards,

Dianne.

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