Well we were told the "preapproval inspection was completed" at a 10 Jan presentation. We were then informed on 22 Feb in the half yearly accounts that the "preapproval inspection was successfully completed, and no more technichal or regulatory hurdles to overcome". I read this as the FDA has completed the ANDA review process and it is only the rubber stamp and a fax to come.
Now apparently the rubber stamp and the fax takes between 15 to 30 day's, oh boy! So we take that period as starting at the latest as the 21 Feb, then approval could be expected between the 7 - 23 March? It could be earlier depending upon the date of the successful completion of preapproval or it could be later..................
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VIRIDIS MINING AND MINERALS LIMITED
Rafael Moreno, CEO
Rafael Moreno
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