Item 7.01 Regulation FD Disclosure
On
The FDA has 30 days to review the Atossa application. As matter of regulation no assurance can be given that the IND will go into effect within 30 days allowing Atossa to proceed with opening the study. The FDA could request that Atossa provide additional information during the review period and Atossa may not be able to provide the additional information in a timely manner or at all which could result in clinical hold or permanent delay in opening or completing the study. These are standard risks associated with typical IND submissions to the FDA.
The information in Item 7.01 shall not be deemed to be "filed" for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the
Securities Act of 1933, as amended. The information contained in this Item 7.01
shall not be incorporated by reference into any filing with the
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