Replies to post #194332 on Avid Bioservices Inc (CDMO)

[stoneroad]

Thank you Hawkfan!!!

[cheynew]

Thanks Hawkfan! That was a good bob and weave on the Avid facility question. He pretty much said "yes" though IMO.

Nice to hear the comments on the betabody patent too.

[BioBS2012]

Thanks for a great summary.

[dia76ca]

Thanks Hawkfan1! I remember your excellent reporting from the ASM last year. You have given us a lot to think about!

Nice to confirm that there are collaborations in the viral application. Bavi will be used in combination therapy...they will want to test for the best combinations.

They are certainly trying to downplay the possibility of stopping the trial after the first look-in. However I still think that it is possible...depending on number of events that trigger it.

And I believe Steve Worsley when he says that they are in "active discussions". They are downplaying everything this year. It is almost a theme. This could be close. The liver data may provide a clue. That could be the first partnership IMO.

[goodplenty100]

Hawkfan, thanks for sharing your hard work
with the board......So much to ponder in a poss. way.

[edcpf]

Thank you.

Based on this:

* I like the answers for the betabodies patent, imaging, viral, enrollment trends, KOLs, and BTD.
* I still think the first look-in might give us the required boost.
* Ebola...I don't even know what to think of it anymore except that I'd give it just a little bit time, a couple of weeks maybe; if we are successful we might ride the wave here.
* Betabodies in preclinical, why still, what's the problem, would be my follow-up question, since the other answers are unusually honest.

[Roger1]

Thank you very much for the detailed report!

[revenue_monster]

Thanks Hawk

[entdoc]

hawkfan1,well-done.thanks for QA summary eom

[MazelMan]

Ty for sharing.

[tradero]

HF thanks for your effort EOM

[PGG76109]

Thank you Hawkfan1 for the big effort.
I swear I will go one day but the cost to travel is like 3,000
shares and makes me choose to stay home. If it ever returns to
glory like fall of 2012 or better I will fly out.
If its at the prices some here dream of I will fly out private!
Thanks again PG

[exwannabe]

One other comment in regard to the post that Um-tiger made about early look-ins. My understanding is that the first early look-in is to look for adverse events and signs of efficacy. If there are too many adverse events, or no signs of efficacy, the trial will be stopped, but early approval is not a possibility at first look-in. Second look-in is when we have a chance at early approval.

That sounds a bit odd to me, though not impossible. First, the DSMB always will watch for safety, so there is no need to schedule a look for such. Generally a scheduled look is for an early efficacy stop, good or bad.

If their is no chance for a good news halt, then why even bother with the 1st look? They could certainly assign at least some small alpha to the first look and give them a chance.

Is it possible what you heard was more along the lines of "don't expect it" vs. "can not happen"?

SK indicated that we are about where they expected to be in terms of patient enrollment (not ahead, not behind, but on track for full enrollment by the end of 2015) and they are expecting (guessing) that that is about when we will have enough events (deaths) to get the second look-in.

That would be 6 months ahead of my guesstimate, but not unreasonable. And they obviously have real data to opine on.

[DewDiligence]

[Andy]: Are any of our collaborations in the viral area?
[SK]: Yes, we have some in viral.

SK must be using a loose definition of collaboration, LOL.

[Robert C Jonson]

Michael, nice recap. I enjoyed seeing you yesterday. Good luck to the Seahawks!

RCJ

[stockweiser]

Thanks.