Avid Bioservices Inc (CDMO)

[Protector]

BioBS2012, your statement is correct and jbain's calc/estimate/assumption is wrong, unless PPHM purposely feeds us wrong data - which I don't belive - and here is why jbain should be wrong:

I added 1 patient PER CENTER every 6 months in my simulator (that is 0.0056 patients per day per centre) and then it shows we will be fully enrolled in 660 days from now given the CURRENT state of open centres and when they opened (using real opening dates following clinicaltrials.gov).

We would then currently have 81 patients enrolled and need another 22 months to enroll the remaining 505. That would bring us, if I start counting including this month SEPT 2014, to JULY 2016 for full enrolment.

If this would be the scheduled enrolment plan by PPHM then Shan has been deceiving the public from the start because everyone could calculate that with the 1 per 6 months per centre you could not enrol 582 patients even if you had ALL current centres open in JUN 2014. The only way would be to open 25% more centres, so about 200 in stead of the announced 150, which already now would be 170+ since we have 138 and missing 33 European centres to make it 100 in the EEA as listed in the filed protocols.

For starters I don't believe in all theories of PPHM willingly and knowingly deceiving the public. Secondly I think Shan and his colleagues are smart guys that would not make such calculation errors (because this would mean 7 months of on the raw estimate WITHOUT margins). And 3rd I know already several places where that assumption isn't holding. Of course jbain will have used 'on average' so some centres would do better then 1/6/1 and others would do worse.

Still I think the VERY minimum enrolment would be 0.25, or 1 patient per 4 mounts per centre, for PPHM to be able to announce an estimation of end of enrolment in DEC 2015. That would be SEPT 2015+some margin months.

Personally I think, given the very good PII results (60% over SOC officially and 133+% over SOC with hindsight on the dose switching) that we can enrol 1 patient ever 2 months per centre (0.50).

Also, many of the centres have apparently Docetaxel experience. So if a Stage III or IV patients becomes available a Doctor should advise him SUNRISE as that is an ALWAYS win for the patient. If he is randomized in the control arm he gets Docetaxel anyway (but possibly at better financial conditions and closer monitoring) and in case of an early stop of the clinical trial by the data monitoring committee he'll get Bavi immediately. And if he is randomized into the Bavi arm he gets Bavi on top of Docetaxel.

Furthermore PPHM clearly participates to a number of events where they repeat the PII 2nd ln NSCLC stuff or have it on their boot which clearly fits the "inform the doctors" effort rather then the "announce new results". I keep saying that Sanofi has an interest of working with PPHM because there is a generic version of Docetaxel on the market. In a package sell (Docetaxel+Bavi) they could partially make up for the price difference with generics (because they would have their cut) and more importantly remain the SOC for 2nd ln NSCLC. Actually in an end-of-line, out of IP protection and generically copied drug as Docetaxel Sanofi can still do good business by selling at the same price as generics because Doctors will then prescribe the original of the copy. And Docetaxel would still be the SOC reducing Doctors liability risk.