Avid Bioservices Inc (CDMO)

[golfho]

In regard to Tandburg1’s post

”The time to complete the previous bavi cancer trials isn't a good comparison for the upcoming trial for two reasons:

1. Those trials included an evaluation period halfway through. This added several months to the length of the trials.

2. Each of those trials were at one center. I would hope the new lung cancer trial will be at multiple centers.”

Thank you very much Tandburg1…
This kind of error catching is what I’m looking for…
I reviewed the PR’s and came up with the following…Perhaps someone can dig up the missing data
I had 17 months for the Georgia breast cancer trial and clear statements as to when the first 15 were enrolled and when the second stage enrollment started ~ 3 months that brings the start to finish for the 46 patients to ~ 14 months

I had 11 months for the Indian breast cancer trial. After reviewing the PR’s in detail it appeared that there was no specific start date reported for enrolling the second stage only a “dosing is underway” statement reported on 4-27-09. So if we use the 1st dosed to 1st 15 patient dosing completed and add dosing underway to 2nd stage completed dosing we get a blistering 7 months…!!!

I had 16 months for the Indian NSCLC cancer trial. The PR’s were not as specific as well; however I feel comfortable subtracting 5 months using the “dosing is underway” PR date, which now brings this to ~ 11 months

That averages out to 10.6 months…Ohhhh…!!! I like that…!!!

I also believe that with the injection of Dr Garnick into the parade; finding centers to perform the trials may be far more easier. The only thing left to slow things down would be the lack of a timely infusion of money.


In regards to Mojo’s post

”I think your missing the point. The NSCLC phase 2 trial that you described as lasting 4 ½ to 6 years is a regular full length trial. That type of trial wasn't one of the options that SK said they would use to win FDA approval. A phase 2 trial that had interim results that are very good could be used for accelerated approval based on that surrogate end point. This is one of the options SK was talking about and I estimated would take about 2 ½ years.

mojo”

Mojo

I’ve revised some of my number and come up with the following:

I still SWAG the design phase to be 4 to 6 month. Dr Garnick came on board at the end of October, SK stated that he anticipates being in several new trails in the first half of the year. Assuming that the design started around Dec. then the April – June time frame to submit the registration to the FDA fits in nicely.

FDA approval time…? 2 -4 months…?

I’ll go with a revised trial duration of 10.6 months…I’ll use 12 months for simplicity’s sake.

I’m not sure that the FDA would approve use of Bavi until the statistical data provided convincing evidence. This is still a small trial; it’s a double blind test. I believe that half of the patients will receive Bavi and the other half would receive a placebo (SOC). I still think that PPHM must demonstrate a significant improvement in survivor data to receive accelerated approval. Please correct me if I’m wrong but It’s my impression that “accelerated approval” is approval before a PIII is started and not on interim PII data.

Regards
Golfho