Replies to post #261136 on Avid Bioservices Inc (CDMO)

[thealias2002]

Now that you've brought this up, I recall seeing the 'super performance' at those sites and being concerned about p3.

[swg_tdr]

jq1234, NOT TO THE POINT, Ph3 was mainly USA, Central and Western Europe, unlike your quoted "distorted" results of Phase 2,

and the Bavi arm performed as expected, that is close to revised Ph 2.

always enjoying your comments

best,
N

[thealias2002]

Another question for you....

If the p2 trial wasn't stratified, as you say, and they identified Asians as being more likely to have a positive outcome inside of the designed trial,....why not pursue registration in China???

God knows it would be marketable there.

[thealias2002]

I've thought about this for a few days and there is a flaw in your argument.

You said Docetaxel performs better on Asian subjects. I'll buy that as I'm sure you can back it up with data, however, here is the flaw; in the p2 trial there were a few sites that raised the bar on overall survival benefit. Being mainly in India, I thought 'perhaps a heavy dose of Asian participants', BUT if that is the case, it only shows that Bavi, too, does well/better with those subjects,.....and that trial was in comparison to Doce as well. With the p3 "failure" and the p2 outperformance (compared to both other Bavi sites and Doce) at certain sites,...to me the question now becomes, 'why were the results so much better in those given test sites', and, 'why did PPHM not review this already to develop a better plan/chance of success for the p3.

I can't find data by trial site......but Bio or someone undoubtedly has it.....