nufacturing and marketing FavId or Favrille's other
product candidates; delays in the availability of data from Favrille's
Phase 3 clinical trial; Favrille's ability to obtain marketing approval for
FavId or Favrille's other product candidates and the timing of any such
approvals, including whether a clinically meaningful response improvement
can serve as the basis for accelerated approval of FavId and whether it
will receive expedited review as a result of the Fast Track designation;
Favrille's ability to demonstrate that its idiotype protein produced from
insect cell lines may stimulate a more effective immune response compared
to idiotype protein derived from mammalian cells; Favrille's ability to
manufacture sufficient quantities of FavId for use in clinical trials and,
if FavId receives marketing approval, for commercialization; risks
associated with achieving projected operating metrics and financial
performance or the anticipated number of patients using FavId; potential
delays in patient enrollment; Favrille's ability to obtain additional
financing to support its operations, including the conditions to the
Company's ability to access the committed equity financing facility and
therefore fund operations through the first half of 2008; and additional
risks discussed in Favrille's filings with the Securities and Exchange
Commission. In addition, conclusions regarding the safety and efficacy of
Favrille's product candidates cannot be made until the results of future
clinical trials of longer duration in more patients are known. All
forward-looking statements are qualified in their entirety by this
cautionary statement. Favrille is providing this information as of the date
of this release and, except as required by law, does not undertake any
obligation to update any forward-looking statements contained in this
release as a result of new information, future events or otherwise.
'/>"/>SOURCE Favrille, Inc. Copyright©2007 PR Newswire. All rights reserved | |
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