Herbal, what I think rgc is comparing is ACL's Phase III trial that failed is similar in that it used Hyaluronic Acid with Irinotecan (an existing drug) to improve Irinotecan's efficacy.
Rgc, not sure if you've seen the recent presentation, but slides 5 onwards may assist with your questions. Seems like they have conducted trials previously (if I am reading it correctly) that were open label. Fairly small numbers though (sub 20 patients).
Like Herbal mentioned previously, the small number of patients in the trial may be ok based on communication with European regulatory body.
I am assuming they would fund this Pivotal trial through existing funds as:
* the previous trials were small so shouldn't be too expensive,
* in their dialogue with regulatory authorities to designing this Pivotal trial this was deemed to be ok and
* they have a little less than 2 years cash so if they get approval this year, then sales in 2016 calendar will offset this burn (depending on take-up of their product)
http://www.oncosil.com.au/wp-content/uploads/2015/03/Investor-Update-March-2015.pdf
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