Cafa, what are you talking about? The blog clearly states that based on hearsay OSL received adverse guidance, that the process has stalled and it was communicated that OSL would require further significant work! (which is code in NB speak to say 'give us more money and we'll pretend this is an ongoing process for you to tell your shareholders').
Which is nothing new, because if you read the announcement dated 9/9/15:
"Upon completion of this review the Notified Body will make a determination to either recommend the granting of CE Mark certification for OncoSilTM, or ask the Company to provide additional information in order to obtain CE Mark certification."
Since a recommendation wasn't made, one must then conclude the application as made was rejected.
Or, you could simply pick up a telephone and ring the FDA!
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Cafa, what are you talking about? The blog clearly states that...
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