Replies to post #268034 on Avid Bioservices Inc (CDMO)

[tradero]

Well of course there should be some sort of side effect

But the question raised by entdoc was if there were none, which would be very stange, and is not well supported by this data

Even if you drink some orange juice there is going to be some kind of reaction in your body. But the point is what level of risk, danger or damage that is going to cause... and with Bavi does not seem to be any risk.

But what it really matters (at least to me) is: will we get any positive results in the Combo trials currently goin on or not yet

This is my main concern, the rest is more beating around the bush
JMO

[Protector]

exwannabe, when we use PPHM's 2nd ln NSCLC results to make a point as to the qualities of Bavituximab and how well it works (60% SOC improvement official with combined arms and 113% otherwise) we get the 'botched trial' response.

But now, if we need to say something about the safety the same data-set is OK to say something about the Bavituximab safety.

Is that what we could call double standards ?

And the way it is presented shows nothing at all. There is NO arm in which there was no DOcetaxel given to the patients. And we have seen, even recently in SUNRISE, that Docetaxel makes strange cat-jumps as it can kill you in in about 9 months (in an Opdivo trial) or make you drastically survive all historic expectations (in a Bavituximab trial) both trials running in the same countries and same time-frame, hence same standard of care. (unless BMY of course only uses second rang hospitals and PPHM only top level which would then have to explain why Docetaxel alone performs so much better in PPHM trials then in BMY trials.).

So sorry if I go for the more official Docetaxel Combined With Bavituximab in Previously Treated, Advanced Nonsquamous Non–Small-Cell Lung Cancer results report and conclusions as quoted out of it by 'eb':

In this trial, there was a lower incidence of vascular events in the docetaxel with bavituximab 3 mg/kg arm (n ¼ 1; DVT) than in the combined docetaxel with placebo/bavituximab 1 mg/kg arm (n ¼ 5; DVT, PE, CVA).

There were no instances of clinically significant, treatment emergent bleeding, proteinuria, hypertension, or visceral perforation. Further, vascular events in both arms of this trial did not exceed those expected with docetaxel monotherapy or in the general context of progressive advanced malignancy.

Separately, immune checkpoint inhibitors targeting CTLA4, PD1, and PDL1 have been associated with numerous immune-related AEs, including pneumonitis, colitis, hepatitis, hypophysitis, dermatitis, and nephritis.1,34-37 In contrast, overt immune-related toxicities have not been observed with bavituximab.

I would, in an opposite way then you - since the used data is of COMBINED ARMS - say/conclude that the control arm had a little (50%) help from Bavituximab and so this quote:

In this trial, there was a lower incidence of vascular events in the docetaxel with bavituximab 3 mg/kg arm (n ¼ 1; DVT) than in the combined docetaxel with placebo/bavituximab

will actually have been even MORE in favour of Bavituximab wouldn't the control arm have had 50% patients treated with Bavituximab due the the CRO, CSM in Fargo, dose switching incident or fraud as claimed by PPHM in its last PACER filings before CSM settled.

I rest my case.