As per Dec 2013 investor presentation: CE/IDE application to be submitted early 2014.
Jan 2014 investor update: GAP analysis completed by "experts", clear path to approval. "We will submit an IDE submission shortly to the FDA". "Regulatory submissions is being compiled and we are optimistic that the process will be completed Q1 2014".
Mar 2014: Oncosil commences pivotal trial. Interim analysis 6 months after 30 patients have entered the study.
Apr 2014: "finalising IDE submission with the FDA."
Jul 2014: "expects to submit an IDE in the near future.""advancing its CE Mark process"
Oct 2014 presentation: timelines now indicate IDE/CE Mark submissing 2H2014, pivotal study to commence 2H2014 (still no patients recruited despite official commencement in March)... goes as far as to suggest first sales in 2H2015.
Nov 2014 investor update: no change to timelines, but a slide to explain "the Delay", " [trial] protocol being amended to meet US and EU regulatory recommendations"
Feb 2015 update: IDE and CE mark aimed for approval in 2H2015. "Pivotal study will be redesigned... expected to commence CY3Q2015"
Mar 2015 update: "plans to file for CE Mark in 2H2015"
As shown above... anyone with at least one brain cell would come to the conclusion that the company is full of it...
OSL Price at posting:
7.3¢ Sentiment: Sell Disclosure: Not Held
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