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Friday, January 22, 2021 6:10:25 AM
I Certainly agree with this, actually a 'game changer' for me is the new endpoints which effectively address potentially serious hurdles to success created with pseudo-progression and crossover confoundment. With regards to the FDA I personally believe they will accept the changes even if later than the UK and EU. The fact is even if we only get approval initially with the UK and EU, many of us that bought in earlier [and averaged down, then up] will do extremely well. I have no doubt at all that FDA, Canada [and more to follow] will eventually approve.
Remember LP stated having "multiple home runs" There is no doubt in my mind she was referring to approval for rGBM as well. Despite the 'noise' the simple fact is the chances of success have increased significantly. Now that we are up to date with our regulatory filings, I can fully understand why LP will take her time to ensure success. Whilst we may miss out on
$$ millions of profit, let us remember she could possibly miss out on
$$ billions. I have no doubt that LP ["Go big or go home"] will win through and results of this will certainly be worth waiting a little longer for IMO. GLTA
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