Avid Bioservices Inc (CDMO)

[biopharm]

So you see that the likeliness of SUNRISE being stopped at 1st look-in is possible but then Bavituximab must really be better even better the in PII and/or the control arm worse. This is however possible because in the PII the control arm patients received Bavituximab and Bavi patients placebo.

CP... I have a question regarding possibly another reason for a trial to be halted and I know it must not come up very often, but it deals with the DMC using all knowledge at their disposal in deciding and looking at all the data when a trial is possibly stopped.

A trial can be stopped for good reasons (to allow all those in the inferior arm to be rolled over to the better performing arm) and for bad reasons ( to stop one or both arms ) if some new information is found such as one/both not performing well or a link is found that do more harm if allowed to continue.

I'm going to concentrate on this "link" and hypothetically name a few things that could happen that I think may have to be taken into consideration:

1) Since the FDA does approve of CTC testing (CellSearch is the only FDA approved one), and measuring of MDSC's is also being researched, what if patients in the trial take it upon themselves to simply get a blood test for MDSC's and that becomes part of their EHR Electronic Health Record. Then... if the trial is stopped by the DMC and they must look at all relevant information and happen to see all patients EHR's and easily notice that MDSC's indeed have decreased in the Bavi/Doce arm vs MDSC's have not decreased or possibly increased in the Doce/placebo arm: Would this possibly be new knowledge that the DMC must consider in stopping the trial and place everyone on the Bavi/Doce arm?

2) Since Peregrine does have KOL's working for them and a couple of them such as Dmitry Gabrilovich and David Carbone may also be working with them (Peregrine) to have some form of blood based biomarker approved by the FDA and if approved the DMC would likely have to consider this new knowledge if it FDA approved and states that MDSC's are directly correlated to overall survival, because if 12 MDSC's in benign tumor was seen to predict MBC metastatic breast cancer 6 months later... it can work in reverse and when the MDSC count decreasing just may prove someone with a metastatic cancer or NSCLC may find it in remission 6 months later.

** I do understand when you mentioned about if a trial is stopped... it may not have beaten the SOC of which it is trying to do, so next I must look into if any FDA approved drugs have actually been approved, though by some DMC stopping the trial on good results but has a DMC ever stopped a trial for good reason and that drug is approved but the "true" MOS advantage over the placebo was never discovered because of the same DMC stopping the trial and placing everyone on the superior arm ?

Hopefully that made sense.... and I wish there was a site that listed all FDA approved drugs that previously was stopped by a DMC and possibly the true MOS benefit listed was inconclusive, only because the trial was not allowed to finish out ( leaving the placebo arm going and by that measure making 50% of the patients take a knowingly, inferior treatment.

*** If it was up to me, I'd get a blood test at lease once a year to measure the MDSC's and get a baseline and continue to monitor so right when I see that increase... one is ready and prepared to take steps many months in advance. I hope CALICO or someone out there is smarter than I and crease some medical device and watch it daily because then you can actually, possibly narrow down exactly what foods/drinks are not good in the longterm but would that be allowed is the question? Its sort of like the next step to placing the amount of calories on a food... stores don't like that because sales go down when someone actually sees it in front of them and it also seems that many BP type affiliates want us to be Fargo blind.