From Bell Potter's research note on 25/3:
NEXT CATALYSTS
There are no significant changes to earnings and the company remains well funded to
commence the US pivotal study.
The upcoming meeting minutes from the pre IND meeting should provide further clarity on
the volume of patients required for the pivotal study. This will be instructive for determining
the extent of the company’s funding. Estimating the cost of a clinical trial is fraught with
error, nevertheless at an estimated US$30K per patient for a 400 patient study the cost is
US$12m (A$21m at current exchange rates). This cost is well and truly covered by our
assumptions in the DCF valuation.
We have previously raised the prospect of a second confirmatory pivotal study – potentially
in Europe. Normally (but not always) new drugs require two phase III trials or approval.
The DCF model includes an extensive allowance for clinical trials in knee osteoarthritis that
should cover most of the cost of a second trial if required. At this time we do not anticipate
a further capital raise will be required.
The requirement for a further capital (if any) is dependent upon many variables may
include the nature of the commentary from the FDA minutes and any future partnering
transaction.
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