La compagnie est allée chercher 1Millions de dollar en Octobre pour demeurer en affaire et "refaire" un demande à la FDA ...
Imaging3 plans to resubmit its application for clearance of the Dominion Vi Scanner under the FDA's 510(k) process," stated Dean Janes, Chairman and CEO of Imaging3, Inc. According to Mr. Janes, "The results of our review with counsel has determined that the 510(k) program remains the most appropriate and efficient route for FDA approval. It was determined that the 'De Novo' and 'PMA' processes were not necessary and with some minor adjustments to our existing package along with some additional information and potentially a pre-submission meeting with the FDA, the 510(k) submission should be successful. I am confident that with the assistance of our newly hired FDA consultants and our new strategy we will be able to provide the Agency with a package that meets their needs to expeditiously approve our device," Mr. Janes added.
The terms of the securities purchase agreement include the sale of 4,587,157 shares of common stock at $0.218. The warrants include: (i) Series A Warrants, which are immediately exercisable for a period of 5 years into 4,587,157 shares at $0.2725 per share.
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