Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-43

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Lopez

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07/01/19

21:02

Post #: 37049635
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Originally posted by Southoz ↑

Originally posted by Techinvestor
@aatisket - we're a little in the dark here because the goal posts keep moving. The original 2016 announcement talked only of HF-MACE (a new measure) as the primary endpoint. Now we also have TCE which kinda makes me worried a bit because it would not be the first time that things have shifted in this trial.

But I guess at the end of the day we're looking at cells vs standard of care - so in both the treated and control groups patients will receive standard of care after an event.

So they should cancel out - but the thing that would worry me would be the potential for this change to introduce greater variation due to differences in post-event treatment and response. I guess in a year or so, we'll all know!

It is pretty inscrutable techinvestor.

The trialnow comprises two composite co-primaries - HF-MACE and TCE. Both are event driven.

And so by moving the TCE events from secondaries to primaries you are in effect increasing the event rate. So shortening the trial length. But the price you pay is that now significance is required on two primary outcomes.

MSB haven’t updated the trial registration to reflect this change if indeed this is wha thas happened. https://clinicaltrials.gov/ct2/show/NCT02032004

It is a complete mystery to why companies don’t wish to inform investors about wha tthey are doing with their trials. I suppose dumb investors can’t ask difficult questions. But really this has now trained everyone up to believe that if anything unusual occurs during a clinical trial (that is referred to in some obscure way by the company)… just sell.

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Hi Southoz,
I read your posts and I understand your pessimism in regards to Biotechs and trial designs.
Point is, on occasion your very wrong.
After your thumbs up for FTT you should give it a rest for a while. imo.
Aloha.

MSB Price at posting: $1.34 Sentiment: Buy Disclosure: Held
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