’So the point is - How much more data do we need ?’
the FDA requires more data than we currently have for approval of the application - its what they need not what we want.
james has stated as soon as we have enough to progress the application we will stop the study
but we also need a greater number of patients from memory I believe closer to 200 treated
GBM agile is the cheapest quickest method - and pre-approved as a study structure for appropriate data to obtain FDA approval so we just need to replicate results we have already had in more patients in a study with a control arm - which GBM agile has.
it’s a frustratingly long process - but a necessary evil - look at thalidomide babies to see what happens when process is rushed and assumptions made with not enough individuals studied.
shareholders fund GBM Agile and the companies overhead at this time - the other studies bar mostly study drug are paid for by the various research partners... we are very lucky in this arrangement - it’s been an incredible achievement to get so much activity out of such a tight budget that’s all our management team
as others and maybe Q will tell you each study, in each phase, is a 20 million dollar value approx until phase 3 and the phase 3’s are usually 40 million... all in USD.
we are in 7... each recording data as we speak and hopefully reporting excellent results soon..
we are in phase 3 hold onto that
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