Thursday, February 01, 2018 4:41:52 PM
"...depending upon additional input from EU and US regulatory authorities, as well as the potential for more than one regulatory filing and approval in calendar year 2018, we may need to raise additional capital prior to the fourth quarter of Fiscal 2018.
"For example, on December 18, 2017, we announced that we voluntarily withdrew a 510(k) notice for AC5 Topical Gel from the FDA, with plans to submit a new 510(k) notice as soon as possible following further discussion with the FDA. In connection with those discussions, we will determine the most prudent path forward, which may include generating additional data and/or submitting additional documentation, and which could increase our cash needs.
"In addition, our estimates of the amount of cash necessary to operate our business may prove to be wrong and we could spend our available financial resources much faster than we currently expect. Further, our estimates regarding our use of cash could change if we encounter unanticipated difficulties or other issues arise, including without limitation those set forth under the heading "RISK FACTORS" in this filing, in which case our current funds may not be sufficient to operate our business for the period we expect.
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