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Hemispherx Biopharma, Inc. Message Board

deepdeepdeepthroat 22 posts  |  Last Activity: Aug 20, 2015 9:12 PM Member since: Nov 22, 2002
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  • Reply to

    alferon age

    by hobbitfanhere Aug 16, 2015 4:29 PM
    deepdeepdeepthroat deepdeepdeepthroat Aug 20, 2015 9:12 PM Flag

    There is simply no meaningful market for Alferon.

  • Reply to

    Could Mr. Equels address the stockholders?

    by mmazza333 Aug 13, 2015 6:40 PM
    deepdeepdeepthroat deepdeepdeepthroat Aug 13, 2015 6:45 PM Flag

    Normal companies have conference calls when they issue quarterly reports.

    HEB is not a normal company.

  • Reply to

    Good Call there MIKEY!!!!

    by jonjonsondd Jul 18, 2015 10:23 PM
    deepdeepdeepthroat deepdeepdeepthroat Jul 24, 2015 7:41 AM Flag

    "scam / scam / scam / scam / scam"

    Is there much else that can be said about HEB at this point?

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 9:04 PM Flag

    "So if a patient improved 30% that doesnt count????"

    Your ignorance of science and math and statistics, along with your paranoid delusional disorder makes explaining these things to you hopeless.

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 9:00 PM Flag

    Once again, your ignorance of science leaves unprepared to understand just how illegitimate it is to change endpoints after you have looked at the data.

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 8:45 PM Flag

    "Hew stupid....can you tell us the reason the fda said they wouldnt allow the original endpoint......"

    jonjonson's reading comprehension is as bad as ever.

    It still has not sunk in that. in its brief of the 2012 doomed NDA, the FDA was holding HEB to the original 20% endpoint from the protocol, not the ones that HEB tried to introduce IN 2007, AFTER THE DATA HAD BEEN UNBLINDED.

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 8:23 PM Flag

    "WHy do you suppose the fda did that"

    Because they wanted to have the opportunity to publicly publish their analysis of just how incredibly shoddy the Ampligen NDA's.

    Yes, it was "unusual," (remember the FDA's warning to HEB in June 2012?). But, it is not every day that the FDA to deal with companies as scuzzy as HEB.

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 8:11 PM Flag

    And the FDA goes on to say:

    For the current complete response, Hemispherx submitted a responder analysis for the ETT results using cut-off values of 25% and 50% change from baseline. In this analysis, the sponsor counts a "response" at any time point during the trial. This approach is problematic because of variability in the endpoint and because it does not demonstrate a sustained treatment effect. The FDA analysis is based on patients obtaining the cut off response at Week 40, the end of the trial. ...The FDA also analyzed the data using a 20% cut-off, as the 20% cutoff was specified in the 1997 version of the protocol that includes a dichotomous ETT endpoint. Note that using the 20% cut off, the difference is not significant (p = 0.19)

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:55 PM Flag

    "Of note, this is different from what the Applicant initially proposed in the protocol from January 24, 1997, which was a 20% change from baseline."

    "The cutoff of 25% improvement was first mentioned in 2007, three years after unblinding of the data. Thus, these analyses should be considered post-hoc."

    Keep reading until it sinks in.

    Any gibbering about the FDA making HEB change the endpoints away from the original ones from the protocol is a 100% lie.

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:45 PM Flag

    Alas, jonjon's deranged false apologia for HEB, claiming that the FDA forced HEB to change the original endpoint is exposed as yet another lie. It was HEB that tried to pull a fast one and monkey around with the endpoints in 2007, THREE YEARS AFTER THE DATA HAD BEEN UNBLINDED.

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:40 PM Flag

    LOL, those were not the cutoffs specified in the original protocol.

    Read my post with the except from the FDA, (and weep).

    In legitimate science, you specify your endpoints in the protocol and stick with them. You do not fiddle with them years after the data was unblinded to try to make things look better.

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:34 PM Flag

    This is the gardening thread. Go back to luc's "Two times rejected by the FDA" and you will see the original endpoint in my post there.

    Or are you so intimidated by that post that you have to pretend that it does not exist?

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:31 PM Flag

    The post was just 20 minutes ago. You can scroll down.

    Yahoo won't let you repeat a post verbatim right away (to prevent spamming).

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:29 PM Flag

    Obviously, my post that quotes where the FDA explains that it was correctly holding HEB to the original endpoints outlined in the 1997 protocol of AMP-516 and that it was HEB in 2007--THREE YEARS AFTER THE DATA HAD BEEN UNBLINDED!!!--that tried to pull a fast one and play around with the endpoints is a post that just simply blew jonjon's mind, and all he can do is mutter gibberish.

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:23 PM Flag

    More importantly than your insane ADCOM misinterpretations is the post in that thread where I exposed your assertions about the FDA changing the endpoints as a false premise. Go back to that thread, and read.

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:18 PM Flag

    from tobaccodocuments dot org

    "Dr. Carter's fundamental premise is that Ampligen delivered in cigarette smoke to the smokers would result in a multi-site stimulation of the immune system in the respiratory and cardiovascular system thus protecting the smoker from lung cancer, emphysema, chronic obstructive pulmonary disease and vascular disease. Ampligen could be applied to tobacco in the field (to prevent Tobacco Mosaic Virus infection), to tobacco in the cigarette manufacturing process or to the filter during cigarette manufacturing. "

    And Phillip Morris' conclusion:

    "Overall recommendation: A low probability of success in tobacco products."

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 7:08 PM Flag

    As usual, his post is based on a false premise.

    The FDA held HEB to the initial data analysis plan of AMP-516 as outlined in the study protocol. It was HEB that tried to fiddle and change the outcome measures in 2007 AFTER the data had been unblinded, which is not how legitimate science is done.

    From the FDA:

    "In the Statistical Analysis Plan from September 30, 2007, a dichotomous analysis was proposed as a secondary endpoint. The Applicant proposed to analyze the proportion of patients with at least a 25% increase or at least a 50% improvement in exercise duration relative to baseline. Of note, this is different from what the Applicant initially proposed in the protocol from January 24, 1997, which was a 20% change from baseline.
    In addition, the protocol was modified on April 20, 2003 so that ETT duration was the sole primary endpoint and KPS was changed from a primary to a secondary endpoint.
    Reviewer’s comments: Multiple statistical plans for a primary analysis have been proposed and there are inconsistencies and ambiguities throughout the submissions regarding the primary analysis. The two analysis plans that were pre-specified prior to data unblinding appear to be the ANCOVA analysis on log-transformed data and the percent of subjects with at least 20% improvement. The cutoff of 25% improvement was first mentioned in 2007, three years after unblinding of the data. Thus, these analyses should be considered post-hoc."

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 6:55 PM Flag

    "Unheard of mea culpa from the fda..."

    jonj49307's post demonstrates a psychotic disconnection from reality.

  • Reply to

    Gardeners

    by ewan_trades_2 Jun 3, 2015 3:07 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 6:53 PM Flag

    deepthroat was the name of the hero who helped expose the truth of Watergate to Woodward and Bernstein.

    There's nothing vulgar about it at all.

  • Reply to

    Two times rejected by the fda

    by luc46linda46 Jun 3, 2015 6:43 PM
    deepdeepdeepthroat deepdeepdeepthroat Jun 3, 2015 6:46 PM Flag

    Yes, and for the second one, the FDA arranged it so that there would be an ADCOM where they would be able to release to the public their analysis of just how craptacular the Ampligen NDA's were.

HEB
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