On the 6th August 2019, IBX announced it had filed pre-submission to begin first in-human study. We are yet to hear the results of this submission, so expecting news:
https://www.asx.com.au/asxpdf/20190806/pdf/4477kswh7q00py.pdfPlease read the third and fourth paragraph. An
investigational device exemption is expected to be filed also, thereby expediating the trial.
Furthermore, for those seeking probably the best summation of the company, please read this report. This was done around IBX being floated at 20 cents in June 2017. It was capitalised at approx. $43 million.
disallowed link/investment-news/one-for-the-long-game-imagion-biosystems-cancer-detection/145161Importantly, the CEO states that:
" The nice thing about medical devices compared to drugs and drug development is that you don't have to do a Phase One, Phase Two, Phase Three study because we are not trying to demonstrate efficacy of a therapeutic approach."
So, once approvals start coming through - for a biotech company - the process could be comparatively shorter.
Obviously much shorter than Phase 1, Phase 2 and Phase 3..
