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Hemispherx Biopharma, Inc. Message Board

  • foreveratrader foreveratrader Oct 9, 2009 8:00 PM Flag

    FDA approval coming in a few weeks after manufacturing issue resolved.

    What's a couple of weeks to wait for FDA approval after several more weeks of getting the manufacturing issues resolved. Dr. Carter mentioned in his interview today that it will only take a couple of weeks to resolve the manufacturing issue then they expect FDA approval.

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    • There is nothing wrong with having enthusiasm for a stock, but I would suggest you temper it a bit. Dr. Carter has by no stretch of the imagination been truthful and straight forward with his shareholders. I feel deceived by him and I dont have much trust in anything he has to say particularly when it comes to the application for Ampligen for CFS. Even the set up for the big interview on Friday for news of little substance left me with a bad taste. HEB will never get any respect if they continue with repeats of "Ameteur Hour". Most importantly, however, if the drug is in fact safe and effective I hope there is approval for the sake of CFS sufferers.

    • BUMPUP

    • I think you should listen to the interview again. I beleive he said, it will take a few weeks to get the toxicology tests done, which needs to be submitted to FDA. He also said that the report on the NJ facility, for manufacturing, will be submitted in Q4. Thus, I do not see any news coming out of FDA till end of Q4 or begining of 1Q 2010.

    • ronindwg Oct 9, 2009 9:58 PM Flag

      News is news but it all comes down to the chart. To many people looking to get rich off this penny stock. The acc/dist has been down hill and people have been jumping in at every little bounce thinking this is the big one, just to be fleeced again and again.I saw it fall hard and knew a bounce was coming so picked up 2000 shares at 1.82 in early am yesterday and sold at the close at 1.99. Holding that overnite was a fools game and it proved it to. The rumor was the good news was suppose to come out this morning and many buyers got taken to the cleaners again. Stop playing the news and learn to play the charts. Forget the news and start making money. As long as the big boys know people are waiting to jump, this stock will stay flat on it's back.

    • I just listened to the interview numerous times and my take is that the pre-clinical tox studies were part of the NDA and requested for by the FDA. Although the study has already been concluded the compilation of the data into reports would not be complete until the end of q4 or q1-2009. He stated "all the boxes needed to be checked" This means to me that until those are submitted the FDA may not announce their decision. I am confused then by the "fall" decision announcement unless I misunderstood previously.

    • Why would they ask to have production issues worked out? Because it is approved they just have to work it out.

    • dabolts101 Oct 9, 2009 8:23 PM Flag

      In May Carter said the exaxct same thing.. A few more weeks...a few more weeks. Well its been 5 months and still a few more weeks. What i got out of the PR today was Carter advising end of 2009 beginning of 2010. qnd that means he just bought himself another 5-6 months.. always a few more weeks.. has anyone on this board been in this stock for more than a month...? 5 months ago I bought this stock for #2.15PPS and here we are in OCT and its 186. FDA doesn`t say they need 2 weeks to a month like carter advised us back in May.. and then 5 months later still not a peep from the fda... I am holding on but i am also getting alittle disgruntled over the BS out of Carters mouth... Just my opinion.

    • Do you think he is being realistic by same a couple weeks??

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