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biosectinvestor

05/29/18 12:16 PM

#174341 RE: exwannabe #174338

It’s always great to claim you were “technically” right when we don’t have that analysis yet, and when the “technically right” analysis is flawed in terms of regulatory analysis but is being evaluated solely on bulletin board and rhetorical terms.
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kabunushi

05/29/18 12:21 PM

#174342 RE: exwannabe #174338

If you are asking whether I think these results are good enough for approval, I say yes, for sure. Blended mOS of 23 implies treatment 25 which is very solid improvement over SOC of 19 or less. Correct me if I'm wrong but treatments with far worse safety profiles have been approved for less improvement that than this.

As for "AVI77 who nailed it.", as I recall he said there's no way mOS is more than 20 months. That's a fairly big miss vs 23 months in my book - large enough to make the difference between likely approval vs likely non-approval. Anyway I predict approval based on the tail results, not just on mOS, which I'm sure you'll say is not stat sig. Actual clinical demand for this improved chance of surviving a lot longer will push this through approval in any case, imo.
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Virgilio

05/29/18 12:32 PM

#174344 RE: exwannabe #174338

Does anybody still really think they are going to get some approval on blended results that are not all that impressive?



Acutally considering cancer, considering GBM, and considering the lack of side effects of the drug, I believe they are quite impressive. The only negative is that they are blinded/blended, though perhaps they might get a bit better with current data refresh (or a bit worse, who knows).
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pgsd

05/29/18 12:34 PM

#174345 RE: exwannabe #174338

1. Prove PFS has already failed, oh that's right you cannot lol

2. AVI77 has not "nailed" anything as this is last years data. Not final trial results.

3. The approval was never going to be approved on blended data, the trial is still running and still blinded.

4. "The paper published today hints at a major breakthrough in the treatment of patients with glioblastoma" Keyoumars Ashkan, Professor of neuro-surgery at King's college hospital in London and the European chief investigator.

5. "These results appear to be remarkably promising" Dr David Jenkinson, Chief scientific officer for the brain tumour charity.

It appears that there are plenty that totally disagree with your flawed logic including these and the 69 co-authors all who are more credible, knowledgable and trustworthy.