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jamtomorrow2

01/05/17 10:16 AM

#5051 RE: XenaLives #5050

Well we all knew that the data would be muddled. The Phase 1 & 2 trials with the halt and introduction of the Ventana diagnostic were bound to lead to muddled data. But I do think that HALO's presentation of all the data was thorough and fair albeit confusing for those who can't be bothered to understand all the implications of the trial problems. So now the big bad news data that AF and AB are focusing on is the overall OS data being worse than control, which HALO claims is skewed by one control patient living much longer than expected. I guess the claim about how one patient in a very small trial can skew the data of course could also work the other way round. I would therefore imagine that there is no chance of HALO submitting an NDA based on this data and therefore we are in for a long wait - hence the market disappoint.
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friendofthedevil

01/05/17 10:17 AM

#5052 RE: XenaLives #5050

Can anyone offer a summary of his criticisms? He may not not be familiar with the convoluted history of this trial. Yes, the stage 1 data is muddled due to the clinical hold. We already knew that. Yes, the high HA cohort was selected (identified) after the stage 2 portion was well under way. (After the HA tool was completed). We knew that. So, it is easy to argue this "cherry picked" cohort is not a good enough representation of the intent to treat population to warrant approval. Maybe. These were all criticisms we have discussed thoroughly on this board. Please let us know if AF (whom I respect) has any other complaint because, if not, that is all old news. I am very happy with the top line numbers I am reading and, at the very least, this bodes well for the rate of enrollment for the ph 3 trial.

I am tied up and won't be able to listen to the cc until tonight but the involvement of Eileen O'Reilly on the call is enough for me to be buying more shares this AM ahead of the call. (Maybe it's ongoing now - I'm 'stuck' at a ski resort with my family and writing this on my phone.). I'm thinking we go up from here.

GLTA