Replies to post #121881 on Avid Bioservices Inc (CDMO)

[volgoat]

The only thing that will beat Bavi is the passage of time.


Going alone in a PHIII will be the end of it, IMO.
Better mouse trap will be here if they try that..5 years and a screw up like they are very capable of and they would have to start all over...Game Over.....

[md1225]

This is it entdoc, everyone has had all the time in the world since 9/12 to get all the shares they wanted under 2/share and under 1/share for those who really knew when to buy.
The next weeks will tell imo if we are going down like PCYC or CTIC.
We all know the street/potential partner wants to hear FDA green light phase 3 or BTD/AA, and we all will know the answer by 7/13 on phase 3 ..... as for BTD/AA any day if at all....

[DrRocker]

ED-I agree that the passage of time (read delays)could be the biggest obstacle for Bavi approval. Regarding frontline results I look back to the beating the share price took when the PFS results were first reported that showed historically very good but similar results for both the Bavi and control arms according to the independent reads. This despite the control arm showing far better than average historical results that would appear to be an anomaly. The stock price went from 90 cents down to 68 cents on over 7 million shares traded March 9th 2012 when the results were PRed. The stock continued to spiral down to a low of 40 cents by Mid-April. From the PR back then;

While the data from the investigator assessments were in alignment with previous published reports for carboplatin and paclitaxel and suggested an encouraging difference between the treatment arms, the unexpected long PFS estimate for the control arm based on central reads confounds our ability to fully interpret this secondary efficacy endpoint," said Joseph Shan, vice president, clinical & regulatory affairs at Peregrine. "We now await median OS data from this study which is the most clinically relevant endpoint from a drug development standpoint."

Geo- I certainly would hope and expect the control and Bavi arms to show good MOS separation but given the murkiness created by the initial independent reads I am not fully confident this will be the case. I would also intuitively expect front line results to be far superior to second line what with starting with healthier patients but FTM dissuaded me that this was a given here. An excerpt from FTM's response when I asked these questions recently;

The only thing that matters is the increase in MOS for the treatment arm compared with the control arm.
There is no way to know if the disclosed PFS results will have any connection with the expected MOS results.
I am not even sure if it is possible to say that you could expect the first-line results to be better than the
second-line results. That would be true if you were talking about a trial comparing two chemotherapy regimens,
but we are not. Bavi is an immunotherapy and I can conceive of reasons for the second-line to be better than
first-line therapy, but to still expect very good first-line results. We know very little about the first-line trial.
We do not know anything about the patient characteristics. We do not even know what ECOG PS scores
are allowed. PS 0-2, or 0-1? The clinical trials webpage does not list this in the inclusion/exclusion criteria.