Avid Bioservices Inc (CDMO)

[Protector]

edcpf, two things.

Could this be a buy signal when longs are overtly pessimistic? I mean no disrespect.

I am a long long, count me out of the "overtly pessimistic", I have never been more optimistic as now and it increases with time.

And those 'overtly pessimistic longs' as you called them are those that were NOT on the ASM. Those that I referred to with my orangutan comparison.

There is a DIFFERENCE between real long long investors being overtly pessimistic OR ASSUMED real long long investors and mood-swingers being artificially overtly pessimistic.

Thanks for the link. I read that post. Good post by the way hawkfan1. I see which part in relation to the look-ins you are referring too and I cannot confirm it. As said before that doesn't mean it wasn't said! I was totally unprepared for the Q&A not being on recording and therefore not prepared for taking notes because for what use if it would have been all on recording.

Fortunately others did take notes and indeed the thing of the BETABODY patents that was also a question. I forgot about that one.

One personal remark about the, apparently private, conversation with SK in which he seemed to have said that they do not expect an early stop of the trial at the first interim look-in but possibly at the second.

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. 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.

The arguments I read in that post (not sure who Um-tiger is), coming from SK, are at the most strange. They have claimed and over claimed and written and repeated in PR's, just not shouted from the roofs, that Bavituximab is safe and has no side effects of its own. On top of that they have proven it in many trial on 400/450 patients (if we exclude SUNRISE because we have no results yet). I do not BUY FOR A SECOND that the first look-in has as one of it's two underlying reasons SAFETY check! NO WAY! I am not saying the post is not authentic, I don't know that, just that SK's statement is strange.

Secondly to check for Bavituximab efficacy is equally strange. Because for one I think they have several trials now with Docetaxel in which they saw very good results. They even had one that was statistically significant in PII which is itself rare according Dr. Garnick. So it cannot be, after SK just said in the SAME annual meeting that he believes that Bavituximab/SUNRISE is going to be a success, he then says they actually do not start from the assumption that it would again show efficacy. SK at some point literally said that he believed in the success of SUNRISE and they extend AVID for it (see hawkfan1 quote below), so that makes no sense.

And even more, it make even less sense because to actually make a real assessment about efficacy they would need to bring the p-value in line on a LOW 'n' value. Otherwise they would never know if they achieved the results by chance. Furthermore they would need unblinded data because to decide if you continue the clinical trial I guess one would like to know on what randomizing (patient sickness in control vs bavi arm) these results are achieved.

If SK would have said they have the first interim look-in to see if the clinical trial wasn't sabotaged again (which I understand is something he cannot really say) then I would have said, OK makes sense. If he says it is for safety and efficacy evaluation (actually something this complete SUNRISE trial is for and of which the FDA found 582 patients were needed to confirm it) then I say, strange. Again, not questioning the poster!

PS1: Notice how also that message emphasizes end of enrolment DEC 2015, hence EOPIII DEC 2016, hence commercialisation late 2017.

PS2: Someone asked about Avid. This is what Hawkfan1 wrote:

Brandon - Are we building out Avid?
SK - We believe Sunrise is going to be successful, so we will need to be able to meet that need, and also, Avid has a growing customer base.

Interesting, I had been wondering WHERE/WHEN SK said that they believed that SUNRISE would be successful but could not recall. Apparently it was in this Avid question during the Q&A.

I am going to stop posting. I have a pile of mail waiting and plenty of other stuff. I'll take a peek from time to time :)