Replies to post #148302 on Biotech Values

[mcbio]

The SNTA trial is not blinded. The company sure had the data in hand for weeks last time as they talked the stock from 4 to 8 w/ wall street analysts in June. No reason to believe anything different is happening this time.

Good points.

didn't show/discuss the subgroup data - are they reversing and considering phase 3 in all adeno? mentioned OS benefit in all adeno specifically this time

I don't think they had definitively ruled out Phase 3 including all adeno before, did they?

[iwfal]

SNTA

The company sure had the data in hand for weeks last time as they talked the stock from 4 to 8 w/ wall street analysts in June. No reason to believe anything different is happening this time.

I am not being clear apparently. My point is that they have been clear that unlike many companies they are not doing running updates of the data set - but instead are doing some form of set interval updates. Whether this is due to 'official' blinding or just good clinical trial practice is not something I chased. Even aside from my conversations with IR (where they mentioned that they had only a small number of dataset updates pre-June)they have said very similar things in the conference calls - e.g. the May telecon where the Corporate Relations VP noted that the analysts knew the data and he wasn't allowed to know yet so he had to read their body language (an odd thing for him to say, but he was very unambiguous about that aspect of how they are doing data updates).

didn't show/discuss the subgroup data - are they reversing and considering phase 3 in all adeno? mentioned OS benefit in all adeno specifically this time

FWIW ever since the June presentation of the ITT Adeno group I've considered it almost certain that if G continues to show the OS benefit in ITT adeno that they would run the ph iii in all-adeno - without any sharing of alpha with subgroups. But if the all-adeno OS weakens enough I'd expect them to either share alpha with subgroups or scrap all-adeno completely.

[iwfal]

SNTA -

The company sure had the data in hand for weeks last time as they talked the stock from 4 to 8 w/ wall street analysts in June. No reason to believe anything different is happening this time.

Actually I believe the above is not true - quoting Safi from the June telecon briefing he noted 'the results are unchanged from our prior interim review 3 months ago' (i.e. they are doing discrete reviews not the running reviews that most companies do - and the early May excitement was probably caused by the first interim review.). He also referred to "our next interim review" (i.e. not a running review) as what would be used for the first medical review (now decided to be ESMO).

Finally note Safi in particular is very clear that the interim analyses need to follow clear protocols to avoid violating the 'integrity' of the trial. (e.g. cleaning the data after unblinding is dangerous).

PS What i find more puzzling than our disagreement about the rigor with which SNTA treats their trial is the fact that no one is picking up on Safi's excitement over the mets data.