Mani,
I've never seen an update on how discussions with a regulator were going in any product under consideration unless something official came from the regulator that must be revealed. I've seen many products where the regulator did demand additional trials and the product was approved after those trials, but in every such case the decision requiring more came rather quickly. I believe that they're considering many things, and rather than approval being delayed, the company may be providing more to get consideration of a tumor agnostic label.
If six months ago the company were told, we'll approve you for GBM, or we'll consider more evidence that a tumor agnostic label, if you're willing to delay approval. What would you do?
I certainly don't know this was the case, and frankly we'll never learn what's caused this to take so long, but I believe anything is possible. It may be a completely different effort, but I also believe they're working diligently on gaining approval of the EDEN in the UK.
Gary
Bullish
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