Lifeline Biotechnologies Reports on FDA Filing Status
26 Octobre 2009 - 7:35PM
Business Wire
Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today
reported on the status of the pending FDA submission of its First
Warning System™, filed in late July 2009.
Jim Holmes, Lifeline's CEO, said, "This past July we filed with
the FDA to determine if our technology and testing of over 600
patients would meet the requirements for a 510(k). We have checked
with our FDA consulting firm, the firm that assisted us with the
preparation and submission of our July 2009 filing, who advised us
that the FDA is running anywhere from 30 to 60 days past the normal
time expected to provide a response. We have been advised to
exercise patience and we ask that our shareholders do the same.
It’s been a long road and we feel we’re getting close. If the FDA
is satisfied with our testing process and the supporting
information is sufficient, we could proceed and file a 510(k)
application immediately. However, the possibility must be
considered that the FDA could request additional testing or other
technical validations.
"If we can proceed with an 510(k) filing, our best estimate at
this time is that it could take four to six months, possibly
longer, for the FDA to clear our 510(k) application. Once cleared
by the FDA the First Warning System™ could immediately commence
commercialization.
"We have had many questions from shareholders and interested
parties concerning the status of our FDA filing; we ask that they
continue to be patient along with us. As soon as the FDA’s response
is received, we will make a press release and post the response on
Lifeline’s website.
"We've also received many questions concerning the prospect of a
reverse split of the common stock. Even though the outstanding
common stock is approximately 2.9 billion shares, we have no plans
for a reverse split."
Safe Harbor: This release includes forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 27E of the Securities Act of 1934. Statements contained in
this release that are not historical facts may be deemed to be
forward-looking statements. Investors are cautioned that
forward-looking statements are inherently uncertain. Actual
performance and results may differ materially from that projected
or suggested herein due to certain risks and uncertainties
including, without limitation, the ability to obtain financing,
successful development of the Company's product or market
acceptance of the product and regulatory and shareholder approval
for anticipated actions.
Lifeline Biotech (CE) (USOTC:LLBO)
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