Replies to post #112627 on Avid Bioservices Inc (CDMO)

[Threes]

FTM,
Thank you for your input, was looking for your take on things.
These #'s are the best out there. What do you think as far as size of the trial.
With a larger group are we Stag Sig.
Can't see FDA holding Bavi. back question is if data will entice BP to step up pay us what were worth and commit to the expense of phase 3 trial.
Considering the recent failures by BP with NSCLC Bavi should be a strong candidate,

[Protector]

FTM, I think that PPHM will have used the wording "conservative" just because of what your are doing.

You are absolutely correct to compare with the 5.6 and I think a partner will do the same. But the FDA would not have accepted that.

Furthermore, just as you use the control arm for its real-world, non administrative FDA regulation, value of 5.6 I figure that PPHM will for its own be able to get more dosage information from the 1mg arm. It may be lost as a stand alone source of clinical data for the FDA but not for PPHM since they know what happened to it and in what amounts.

[Fire Fox]

FTM-- Thanks for getting out this summary chart so quickly-- it's the picture that is worth ten thousand words. Today the BPs with whom we are talking partnership are looking at the data in this chart, not at the pps.

Could you please help me confirm an important point that appears to make Bavi results today even stronger. In you post #110144 your chart reports that in the Bavi 3mg arm 24.4% of the patients were ECOG PS 2. Where did you get that number? Was it based on all 40 patients as reported back in Sept.? Is it still a valid number today?

ECOG PS 2 patients are MUCH sicker than the PS 0 and 1 patients.

Everyone should review FTM's chart in post 110144 and notice that the 3 other trials reporting treatment arm MOS greater than 10 months (i.e. Herbst in 2010, Pallis in 2010 and Ramlau in 2012) had PS 2 populations of only 1%, 11.9% and 4.6% respectively.

BPs will surely notice that Bavi achieved MOS of 11.7 months in a patient population having twice as many very sick PS 2 patients.

[hayward]

freethemice

Can you please comment on the following

Chicago Tribune: 2/19 12:42pm Analyst George Zavoico

Quote:"I think what may be contributing to the (share fall) is that the difference in overall survival is not statistically significant," McNicoll, Lewis & Vlak analyst George Zavoico said in an email.

AT the same time you are saying

I consider this a doubling
of MOS since the original control arm MOS of 5.6 is what I am comparing this with, in that case we have a 109% increase.

Is MOS and Overall the same thing only one is broken down to months/overall ?

Thanks Michael