Replies to post #48673 on Avid Bioservices Inc (CDMO)

[nh]

Thanks, Sunstar, good post. EOM

[MobyInvestor]

Peregrine has most of the P2 cancer data now, and has shared it with FDA. It must be very strong data. The company and FDA seem to have agreed on a P2 trial that will, if consistent with previous results, lead to accelerated bavituximab approval for second-line NSC Lung Cancer. The company (Avid) has already stockpiled large quantities of bavi.

...

I believe bavi will be approved to treat cancer in calendar year 2011.

So, you and a few others here were able to come to that conclusion while legions of well-funded institutions and biotechnology analysts, every single one of them, couldn't?

Right...

Regards,

moby

[swg_tdr]

sunstar, great post, thanks
NHwild

[mojojojo]

sunstar,

If the data is good, it looks like the soonest bavi could get approved would be the first half of 2012. On last weeks CC SK said:

The size of the trial for the double-blinded placebo-controlled 2nd-line combination with docetaxel, we’re anticipating a 120-patient clinical trial. We haven't publicly disclosed anything on the front-line study yet – we’re still finalizing the protocol and some of the particulars on that. Our goal is to enroll the study in approximately a year. Obviously, the key for meeting that enrollment criteria is to have an adequate number of sites, so we’ve done some feasibility studies, looked at the average of number of patients they think they can put on per month. And then we’re kind of powering the number of sites to achieve that enrollment goal. So once we get started, we’ll be able to really look at how it’s tracking, determine if we need to add more sites on, but our goal is to get it done within a year, which should put us in a good position for data from the trial in late 2011 or early 2012, but ideally late 2011.

mojo

[wxcbs]

So, if all the data is good and it always seems to be, why can't we get one analyst to cover the stock????? Are we on anyone's radar or just our own little radar????

[Charlie Stein]

"This Phase II trial will be a randomized, double-blinded study comparing docetaxel plus bavituximab versus docetaxel plus a placebo. This is a very rigorous study designed with many features typically reserved for Phase III trials and results will be reported when the data are unblinded at the end of the study."

I like that. I've been burned on a Phase 3 that apparently wasn't blinded for the administering doctors. They saw that the patients in the best-of-care arm weren't doing well and then broke the regimen to continue treating them with additional chemo doses, so that the drug being investigated was no longer being compared to a known regimen. The investigatory drug did not do significantly better than the new regimen, and it and the company crashed and burned.

So it's critical to have a trial that is designed properly, and I'll trust that Dr. Garnick knows what he's doing.

But . . . do we really trust the Indian data? Are we sure they didn't just make up some numbers to make us happy? I think that the overseas trials, the small sizes of the trials, the fact that so many early trials lead to later large-scale trials that fail, are all part of the reason that we don't have institutional interest (in addition to the aforementioned "going concern" warning).