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well, cuz I signed up for the FDA emails and updates from CDER last week, but since the whole fda meeting for ampligen was rescheduled, I doubt they would have gotten to it by now, but...it wasn't approved to this date, but it doesn't say that it was disapproved either
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The staffing issues at the FDA don't seem to be affecting these other approvals?
What gives? |
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Article here:
The Hostile React-o-Meter blew up Thursday after the posting of my bearish column on Hemispherx(HEB Quote) and its chronic fatigue drug Ampligen. Dozens and dozens of emails poured in, but not a single one contained an intelligence response or answers to the facts, questions and concerns posed. Paul C. (he's a multi-millionaire, he tells me) wrote to threaten me with a lawsuit because I wrote a column that moved the stock. "You should not be writing articles that after they are published makes the stock move in one way or another, this is stock manipulation." Funny, I thought it was journalism. And then, of course, there was the cursing and the name-calling. Lots of cursing. Lots of name-calling. According to my email friends, I'm bald, stupid, evil, ugly, a psycho, a "looser" (people have trouble with this one. It's "loser" not "looser") and a moron. I'm manipulating the stock lower so I can buy more, but I'm also helping my short-selling buddies. I have a personal vendetta against the company. I'm being reported to the SEC, the FTC and various other three-lettered agencies of the federal government. Jim Cramer is my puppet master and he's bald, too. Lastly, I'm Jewish (I love when that one gets tossed onto the pile.) Can't anyone out there come up with an original putdown? I did receive a handful of thoughtful emails, so all is not lost. Michael R. writes, "Thank you for the write up about Hemispherx. I'm disabled with CFS (and a RealMoney subscriber) and I've followed the Ampligen story with interest for about 15 years. You did an admirable job of writing the history of this drug, and of Hemispherx. It's a complicated story. The drug company has done a terrible job of getting this drug to market, as you detail. "You are probably correct that it will not be approved. This will be a shame. I personally know people with CFS whose lives have been saved by Ampligen. CFS is a crippling illness, and just because you don't die, it wrecks lives. There is no known treatment. Ampligen's approval would be a huge benefit, giving hope to hundreds of thousands of people. Thanks for listening to one voice in the wilderness." My intent was not to delegitimize CFS, which I'm sure is a terrible burden for people, as Michael expresses. But he also seems to understand that I write about biotech stocks and investing, which means taking emotions off the table to examine the facts as presented and make a call good or bad. I could write all day long that I hope every drug works and that they cure disease and end suffering. But if I did that, I wouldn't be honest, nor would I be doing my job. |
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Stars...for what it's worth, I'm having trouble with cut/paste feature also. Further, the editing tools don't permit us to edit hidden html in text...
which makes it nearly impossible to remove all that crap embedded in text we cut/paste from the web.
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WSJ's Article on HEB See? It's [ur1=(link) ] (What you want the link to say here) [/url] edit- to make it show I made it ur 1 (that's a 1, not L) the full string = (What you want the link to say here) Last edited by Hotchkiss1987; 05-29-2009 at 11:03 AM.. |
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Well here's the list from that link
Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type * Review Classifi- cation ** Company Approval Date CETRAXAL (NDA # 021918) CIPROFLOXACIN 3 S LABORATORIOS SALVAT 05/01/2009 CYCLOSET (NDA # 020866) BROMOCRIPTINE MESYLATE 3 S VEROSCIENCE LLC 05/05/2009 FANAPT (NDA # 022192) ILOPERIDONE 1 VANDA PHARMA 05/06/2009 LAMIVUDINE; ZIDOVUDINE (NDA # 022356) LAMIVUDINE; ZIDOVUDINE HETERO DRUGS LTD 05/07/2009 LAMICTAL (NDA # 022251) LAMICTAL 3 S GLAXOSMITHKLINE 05/08/2009 ACTOPLUS MET XR (NDA # 022024) PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 3 S TAKEDA GLOBAL 05/12/2009 CIMZIA (NDA # 125271) CERTOLIZUMAB PEGOL UCB INC 05/13/2009 PREVACID 24 HR (NDA # 022327) LANSOPRAZOLE 5 S NOVARTIS 05/18/2009 NICORETTE (NDA # 022360) NICOTINE POLACRILEX 5 S GLAXOSMITHKLINE 05/18/2009 SAMSCA (NDA # 022275) TOLVAPTAN 1 S OTSUKA PHARM 05/19/2009 OXALIPLATIN (NDA # 022160) OXALIPLATIN TEVA PARENTERAL 05/22/2009 ADCIRCA (NDA # 022332) TADALAFIL ELI LILLY 05/22/2009 |
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UberTrader
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Can anyone point out to me on the list where "HEB" product is? Ampligen, right? also Alferon?
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Before doing battle, in the temple one calculates and will win, because many calculations were made." Sun Tzu |
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LMAO!!!! Oh guy, you slay me.... We have to get you a day job or at least redirect your ability to find those little gems...maybe not....hehehehehe...
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UberTrader
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Hell, i need a job for an other month or so, i'll do it!!!!!..I will even submit the article to stockrants masterminds before editing!!!!!
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Before doing battle, in the temple one calculates and will win, because many calculations were made." Sun Tzu |
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You can edit the tags/adds out of everything. Last edited by Hotchkiss1987; 05-29-2009 at 11:16 AM.. |
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| BDSI, DNDN, DVAX, HEB, Hemispherx BioPhama |
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