ME/CFS patients on trials of Ampligen and some
have done incredibly well for long periods of time
after being on it for about 18 months and others
felt no improvement at all.
Recently, Hemispherix Labs (AMEX:HEB)
posted some news about new trials they
were about to start and at the same time
we have news about a class action suit
being brought against them for withholding
info about request for info that was not complete
that needed to be submitted to the FDA.
I will present both sets of info for you here to read.
Nov 10, 2009
Dyer & Berens LLP (www.DyerBerens.com) today
announced that it has filed a class action lawsuit
in the United States District Court for the Eastern
District of Pennsylvania, Civil Action No. 09-cv-5262,
on behalf of all purchasers of the securities of
Hemispherx Biopharma, Inc.
("Hemispherx" or the "Company") (AMEX: HEB)
between February 18, 2009 and October 30, 2009
(the "Class Period"), for violations of the federal
Securities Exchange Act of 1934.
The complaint alleges that, during the Class Period,
defendants misled investors regarding the status
of Hemispherx's New Drug Application ("NDA")
for Ampligen with the U.S. Food and DrugAdministration ("FDA"). Specifically, defendants
failed to disclose and misrepresented the fact
that the FDA had requested several reports
from the Company before the NDA could even
be considered, thus delaying the possible
approval of Ampligen by several months
at a minimum.
On November 2, 2009, when the Company
belatedly disclosed this information, the per share
price of Hemispherx's common stock dropped
from $1.45 on the previous day to $1.13,
a drop of more than 20%. The next day,
one commenter characterized the November 2nd
Company "update" as essentially an admission
"that its prior public statements were
false and misleading."
Tuesday, November 2, 2009
(makers of Ampligen)Hemispherx Biopharma Updates Chronic Fatigue
Syndrome (CFS) Treatment and Commercial
PHILADELPHIA, Nov. 2, 2009 (GLOBE NEWSWIRE)
-- Hemispherx Biopharma, Inc. (NYSE Amex:HEB)
(the "Company"), announced a two-prong CFS
clinical mission for November and December 2009.
The Company plans to widen its ongoing clinical
programs in CFS by accelerating collaborations
with a consortium of researchers who have just
discovered a retroviral link to
Chronic Fatigue Syndrome. A clinically validated
test to detect retrovirus antibodies in patients
plasma is also currently under development
(please see US National Institutes of Health ).
With the consortium of researchers at the
Whittemore Peterson Institute, the Company is
also now evaluating the defect in
immunosurveillance in specific subsets of
CFS patients in a clinical study entitled
"Therapeutic Activation of NK lymphocytes to
Alleviate Chronic Fatigue Syndrome."
These immune defects may be due
to the previously undetected retrovirus.
The Company also plans to complete all
outstanding queries from the FDA regarding
its New Drug Application (NDA) for Ampligen(R),
an experimental therapeutic,
during November and December, 2009.
On May 26, 2009, the Company announced a delay
on the Ampligen NDA which, at the time, had a
PDUFA date of May 25, 2009. As noted in the
10-Q and 10-K filings at the time, the FDA did
not request "additional information" from the
Company at that time. However, several
outstanding NDA items, requiring Hemispherx
responses, existed at the time of the FDA delayas noted in the August 8, 2009, 10Q filing.
Between March 9, 2009 and September 15, 2009,
the Company issued six (6) new reports to the
Agency spanning various subjects including
a) clinical safety assessments,
b) specialized pre-clinical toxicology reports, and
c) abbreviated chemistry and manufacturing
The Company believes that these reports may
fully retire all Agency queries in these
The Company also plans to submit four (4)
additional reports on interrelated topics in
November and December, 2009, which will
include pharmacokinetic analyses in multiple
lower animal species (primates, rodents, etc.)
("the Lovelace Laboratory Studies") and final
validation reports of certain manufacturing
procedures conducted at an independent facility,
Hollister-Stier Laboratories in Spokane, WA.
Some of these reports were recently cited in
BioMedReports.com and the
Science Business Exchange (October 15, 2009).
Information contained in this news release other
than historical information, should be considered
forward-looking and is subject to various risk factors
The Company disclaims, however, any intent or obligation to update these forward-looking
statements. Clinical trials for other potential
indications of the approved biologic
Alferon N Injection® do not imply that the product
will ever be specifically approved commercially for
these other treatment indications;
Similarly, the completion of NDA filing process
with Ampligen® does not imply that the product
will ever be approved commercially.
"partial press release" reprinted from:
Personally as an investor that HAD owned HEB
during the time mentioned in the class action suit
I agree that HEB was NOT forth-coming with theactual facts of the matter...However, as I was NOT
in for the "long haul" but the trade>had let the stock
"pop up">sold my holdings>made my profit, and
was a Happy Camper. I will NOT be participating
in the class action, however I had a feeling back
then when I was reading their website and saw
some weird changes being made that something
was a bit "fishy" as they say...
Unfortunatley, in this day and age, whether you
are a patient or investor
the Same RULE applies: