Replies to post #204734 on Avid Bioservices Inc (CDMO)

[InternetForumUser]

I wasn't aware of them staying open for the duration of the trial. I thought each site had a specific number.

[Protector]

geo, I agree they keep enrolling until all patients are accounted for.

This was said to be a competitive enrolment.

Europe 345 patients (for 77 out of 100 planned centres in Europe)
Russia 55 patients (for 7 centres in Russia)
Rest 182 patients (for 38 US, 31 Australia, Taiwan, Korea, Ukraine centres)

So actually those last 38+31=79 centres have max. 182 patients to share or
2.3 patients on average. The Russians 55 patients for 7 centres or 7.71 patients on average.

Now lets assume the 38 US hospitals get 3 patients (38 x 3=114). Then 182-114=68 patients left for the remaining 31 centres or 2.19.

The 28 of the US Centres were open in MAY 2014. So they have more time to enrol and they have been visited by PPHM personnel.

So if patients amounts would have been assigned then the US centres that are open 14 months now should have had their 3 patients and and stop recruiting. They had 4.5 months per patient.

Yet clinicaltrials.gov shows all centres as still recruiting.

So either ct.gov is not up to date, or PPHM can NEVER enrol the remaining patients in time (they'd need more then 300 days for the remaining patients on a 1 per 135 days per centre basis), or they keep enrolling in the competitive system and those that have some more compensate for those that are short.

Of course if PPHM would deliberately allow incorrect data on clinicaltrials.com, knowing that all investors follow the SUNRISE trial on PPHM's advice (see PR's), that would of course be something different.