Replies to post #195201 on Avid Bioservices Inc (CDMO)

[honestabe13]

Dew..since the patients would still be taking a regular dose of Docetaxel for second line (as the SOC), why wouldn't they or their doctors be interested in entering this trial with the possibility that an additional molecule, with a well-known safety profile, MAY boost it's effectiveness?

how did you come up with your ratio?

[bigbro1]

you are right ! its 2 patient for 10 sites. each patient has to visit 5 differnt sites for their dosage for each visit. good going !! any other good estimate/prediction from you ?

[geocappy1]

I think the idea of bavi being a placebo, phII not being accepted, not getting to phIII is closer to the truth than this estimate of the number of patients enrolled. Add it to the list. Can't wait to see the next one.

[edcpf]

This is wrong. The company gave us a hint in the last PR, which shows that SUNRISE should account for 200+ patients.

[djohn]

10/15/2014 PR
"To date, bavituximab has been administered to over 600 patients worldwide and appears to be safe and well tolerated."

Shan’s statement May 20, 2013

"The promising survival and safety data from the Phase IIb clinical trial in second-line NSCLC combined with the safety profile from over 400 patients treated to date with bavituximab provide strong support for this Phase III clinical trial," said Joseph Shan, vice president of clinical and regulatory affairs of Peregrine.

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=765925

[Protector]

If your estimate is correct then PPHM will never enrol the 582 patients for DEC 2015.

My estimate is 1.5-2 patients for every 10 sites.

And you wrote that yesterday so I connect that date to it for the calculations because the maths are simple. 14.6 x 2 = 30 patients (rounded) yesterday.

We currently have 19698 centre days shared by those 146 centres that are currently open. That is because the first centre is open 302 days, a centre that opened on May 3rd 178 days, etc (you just sum them up).

So 30 patients equal 19700 (both rounded) centres days.
So 19700/30=657 centres days PER 1 patient to enrol.

So 582-30=552 patients to still enrol at 657 centre days per patient is 552x657=362664 centre days needed.

We produce 146 centre days per day so 362664/146=2484 calender days needed (provided we stay at 146 centres). But even assuming PPHM has 175 centres open tomorrow, then we would still need 2072 calendar days. I'll be mild and take those 2072 to continue with and not the even worse 2484.

We are OCT 28th 2014 and end of enrolment of the 582 is DEC 2015 according PPHM. So that leaves about 426 calendar days if we stay on track.

With your estimation PPHM would finish 2072-426=1646 calendar days later. That would bring us to JUN 2019 for end of enrolment.

Now DD, you know I am an absolute PPHM fan, but I agree they are not flawless and can make mistakes, certainly in things were you need to estimate based on lots of unknown factors. BUT missing their end target by 4.5 years? No, that is just to much.