Replies to post #117367 on Avid Bioservices Inc (CDMO)

[MazelMan]

FTM

Thanks for sharing

Dave

[cheynew]

Do you think it odd that they need 3 additional sites to enroll just a total of 12 participants? I thought this would be done very quickly (as in completed by now) since it is only a 3 day treatment study period. What am I missing?

Primary Outcome Measures:
To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

[Protector]

man, you are monitoring that in such a detail!

This could point to the fact that they want to speed up this trial!

Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors.

Combined with Washington that are 4 sites now, that means:
A) Only an average of 3 patients per site
B) Spreading the risk for tampering
C) I suspect them to have added these sites as a late announcement so there is not much time to prepare for any tempering scenario.
D) They reduce the risk if real error introduction be providing comparative means between site.

They could announce this on AACR, as a side item inside a presentation, because this is still a very research/academic thing.
Or, who knows, since they need only 12 patients for 3 days they may even have some intermediate results at AACR.

I don't think this trial will have problems to enroll and it will probably go very fast. They may even have the patients already and not relay open/close enrollment in the traditional way (if that is allowed).