Replies to post #258183 on Avid Bioservices Inc (CDMO)

[patientlywaiting]

Thank you R C Jonson!

""how can we say that it was the Bavi that was working in the treatment arm"

and to continue that thought the common denominator to both arms, CHEMO.

We are all just GUESSING until we see the DATA........

[Protector]

Robert C Jonson, because of what working means.

If you apply Docetaxel for two decades on millions of patients and you have main studies that also show that patients in Stage IIIb and IV with ECOG 0,1 have a median of 10.4 months MAXIMUM (Herbst et al 2012 9.9, Doce alone vs Opdivo last year 9.8) then every performance of DOCETAXEL outside a range of say 9 to 11 months is for sure a NON STATISTICAL SIGNIFICANT result.

For the Bavituximab ARM at EQUAL performance at the moment of the look-in you have the Bavi studies that show that Bavituximab does indeed increase the survival. You have the substance that you can BLAME :) for living longer. With DOCE Taxel alone you have not and so that is for sure an anomaly because you do have prove the median is 10 months.

So if the IDMC sees an expectation for Bavi of 14 months (and bavi performs as expected) and the control arm outperforms as an anomaly setting down also, say, 14 months, then the IDMC can NOT ASSUME that Bavi will perform better then the EXPECTATION.

With the same IDENTICAL 14 months and a control arm according historical results on thousands of patients Bavi would have become SOC for 2nd ln NSCLC, beating even Opdivo by about 2 months.

So can you HONESTLY say that a drug like Bavituximab that scores 14 months doesn't work when Opdivo at 12.4 months works because the SAME DOCETAXEL treatment in the control arm scored 5 months LESS.

Or would BMY say that Opdivo doesn't work if their control arm would have done 14 months? This is PURE nonsense and costs LIVES because poor regulation, the ever lasting procedures and an FDA that does not progress with reality.

Because according the SUNRISE TESTS Docetaxel is NOW AGAIN the SOC for 2nd ln NSCLC, it has BEATEN Opdivo if it outperformed the 12 months expectation DRAMATICALLY. I need to assume that dramatically is not 0.4 months.