An EXCELLENT read. Thanks for posting localhero.
It indicates to me that the Stage IIb trials PLUS the Stage III trials will cost a TOTAL OF US$13 MILLION!!! Which means very little further funds need to be raised...
Far less than what those so called expert biotech investor downrampers were alluding too...hey decan :)
FROM THE REPORT:
Further, the establishment of a $12 million funding facility (discussed
below) has largely addressed funding risk and ensures that phase
IIb/III pivotal trials can be progressed. The cost for phase IIb trials is
US$4 million and for phase III trials is estimated to be between US$7-9
million, with most of the expense for phase III trials expected to be
incurred in the latter stages of the Phase III trial timeframe.
The company had initially expected to conduct trials on ~340 patients
over three tranches, although based on discussions with the FDA, the
company may only need to conduct a randomised 60-patient trial. The
trial is likely to require 15 sites in the US and 15 sites in Australia &
New Zealand.
The main focus of Phase IIb trials has not yet been determined, but is
unlikely to include the stabilisation of CA125 levels, as was the case in
Phase IIa trials. Phase IIa trials were conducted on late-stage terminal
patients, with the next trial to be conducted on healthy patients; hence
the results are likely to be more effective.
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- awesome read...thanks localhero
An EXCELLENT read. Thanks for posting localhero.It indicates to...
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