I too like your post, thanksThere are many reservations in my...

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27/10/21

10:56

Post #: 57106169
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Originally posted by Zenox: ↑

IMO PAR definitely knows some of the results for 008 since the database is not locked and only PAR knows what each participant received. I'm also sure Boxhill would've been providing regular updates to PAR who are (as you pointed out) free to look at the data as they choose.

It is also highly probable that PAR know the primary outcomes from the first 30 recruits, also as you pointed out. I was initially skeptical until i seen the following:

Primary outcome

"Change from Baseline at Day 56 in one or more synovial fluid biomarkers, including but not limited to cartilage oligomeric matrix protein (COMP), C terminal telopeptide (CTX) -II, NGF, interleukin (IL) -1ß, TNFa, IL-6, a disintegrin and metalloproteinase with thrombospondin motif 5 (ADAMTS-5), ARGS (aggrecan cleavage fragments, tissue inhibitor matrix metalloproteinase 1 (TIMP-1), CTX-I, and type II collagen (C2C). Synovial fluid biomarker samples will be taken at Baseline and Day 56."

The key phrase here "Synovial fluid biomarker samples will be taken at Baseline and Day 56" indicates that when each patient reaches Day 56 their synovial fluid samples are ready to be analysed. That is, PAR doesn't have to wait for patient 30 to complete Day 56 to begin analysis.

This would also mean PAR were likely in receipt of some of these results prior to halting 008. The fact they have: 1) expanded this study to another site (making it a "multicenter" study), 2) extended the period to 12 months to examine durability and 3) including a 3rd cohort to receive a single dose for 6 weeks, also tells me they've achieved the primary endpoint are are looking to maximise the value out of this trial without compromising its statistical integrity.

A very smart move if true.

My opinion only, not advice.

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I too like your post, thanks
There are many reservations in my mind, for instance -
As a double blind placebo study looking for 60 participants -
30 turned up
how many pulled out before day 56?
is it assumed from the start, every 2nd participant gets the Zilosul, remember it's randomized?
there may actually be less, rather than 15, or conversely more because it's randomized.
Thank goodness I'm in for the long haul!
Cheers, Skip

PAR Price at posting: $1.89 Sentiment: Hold Disclosure: Held
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