Red Drag here is something to think on.....But thank you for the good tips and good luck on your new investment.... other than the insider moves by katz i think we may be ok...yet.
clinical data.....for Lidakol
Jan 29 1998
8:17 P.M PST
The Company initiated two Phase 3 studies (96-LID-06 and 96-LID-07) in the U.S. in July and
September, 1996, both of which were early-treatment protocols. Almost 750 patients were evaluated in
these double-blind,placebo-controlled studies, the primary endpoint of which was overall
time-to-healing, with secondary endpoints including percentage of aborted
outbreaks and relief of pain symptoms. The studies were conducted at many of the same sites used in
earlier Phase 3 studies of LIDAKOL.
In August, 1997, the Company reported that in the primary end-point of these trials, treatment of acute
herpes episodes with LIDAKOL resulted in a statistically significant (P=0.0076) reduction of the healing
times versus the placebo control. LIDAKOL also demonstrated statistically significant (P=0.0027)
reduction in the time until patients were free of rpes-associated symptoms, which included pain, itching,
tingling and burning. As observed in previous studies, there was a higher incidence of aborted outbreaks
in LIDAKOL-treated versus placebo-treated patients. In one subset of patients, the difference in
aborted episodes between LIDAKOL and placebo treatments was statistically significant (P=0.048),
but the difference was not statistically significant among all patient subsets.
These trial results provided the Company with the final clinical
evidence to support all of the requirements for filing a NDA with the FDA for
marketing approval of LIDAKOL in the United States as a treatment of recurrent
oral herpes. On December 22, 1997, the Company filed its NDA with the FDA for marketing approval
for LIDAKOL in the United States as a treatment of recurrent
oral herpes. If the NDA is approved by the FDA, the Company believes that
commercial sales could commence shortly thereafter.
LIDAK Pharmaceuticals Receives FDA Notice of Acceptability Of Its New
Drug Application for LIDAKOL(R) Topical Cream
LA JOLLA, Calif., March 3 /PRNewswire/ -- LIDAK Pharmaceuticals (Nasdaq: LDAKA - news)
announced that the
Company received official notification on February 26, 1998 that the New Drug Application (NDA) for
LIDAKOL Topical
Cream was accepted for review. The notification that LIDAKOL had been officially accepted for final
review by the U.S.
Food and Drug Administration arrived 60 days after the submission of the NDA requesting marketing
approval for LIDAKOL
as a treatment for oral herpes (cold sores, fever blisters).
James E. Berg, Vice President of Clinical Affairs and Product Development said, ''While we were
confident that the
LIDAKOL application was complete, we were nonetheless very pleased to receive official confirmation
from the FDA that
our NDA has been formally accepted and is under review for the marketing approval of LIDAKOL.''
luis
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