Replies to post #255521 on Avid Bioservices Inc (CDMO)

[biopharm]

They will be announcing the Betabosies patent soon and what if they announce the results of the Sunrise in early 2017, what BP has an interest in Bavi + chemo when they are aware that the next generation betabodies exist?

Good point geocappy1 and I would think that anyone of them BP's would like to have as much information as possible on patient data re: PS Targeting

If Peregrine shows that the a certain chain of events will happen when we target PS whether it is from Bavituximab or some other PS Targeting drug / betabodies..etc and they can prove the same chain of events occur, but at a faster pace with betabodies ?? then yes, Peregrines may find it in their advantage to get full access to all this Sunrise data now, vs 10 months from now as was planned

Faster chain of events to provide an optimal immune response and stays in the body longer for less treatments ..etc

I think we see all the benefits but I think it will take Peregrine to surprise everyone once more to convince some that thought the same thing on the phse IIb in that the data was not going to be used.

We are not even talking about what was once thought to be corrupt data like back in the Phase II .... we are told right up front the "Bavi+Doccetaxel" arm all going as expected. Those are the key words.

[masshysteria]

geocappy - here's a take on possible sequence of events and reasoning;

Peregrine stated they will PR results of IDMC recommendations when they occur. That is a commitment, from an investor expectations and corporate communication perspective, by which they need to abide.

First look-in takes place at 33%. Committee reviews and produces recommendation. Recommendation is communicated to Peregrine.

Peregrine is offered an opportunity to look at some data. Limited in it's reach as this exposes information that can taint the double blind nature of the trial should Peregrine decide to continue.

Based on whatever their criteria was, and I'm sure it's complex and broad, Peregrine decides to halt. It could be to limit further damage at a later point, to reach for information that would have better purpose presently than at a later time, or truly to figure out what's going on if the problem looks even more perplexing. There is no other way to do this than unblinding/halting.

Peregrine informs the FDA, discusses, and shares decision.

Peregrine informs the investor community (Thursday).

Under all circumstances and unless the committee's recommendations are benign (continue, nothing special here) - Peregrine would have to PR the fact that a review was completed, what the recommendation was, and what the decision is. Futility, Safety and other consequential outcomes can not be internalized without full disclosure.

With that, the risk of continuing (if that was their decision - in opposition to IDMC recommendation) and putting that dark cloud over their heads (Sunrise is going nowhere - why are they bothering) is a no win. The sum of the parts likely paints a picture that says -

Halt
Let everyone know
Take the beating
Get the data
Comfort everyone else (AZN, etc.)
If there is beneficial data from Sunrise, or any learnings, use to your advantage where possible and at appropriate time
Continue to execute on all other channels (provided they are not effected).

If everything else is ok with the platform, and the rest of the collaborators continue to expand engagement, this will be a distant painful memory, and better now than living with it for the next 8-10 months of the trial (futile but continuing)

If there are bigger problems, we will find out soon and none of this will matter for the next several years. Not a happy ending.

Hope this helps.

Best,

MH

[Protector]

geocappy, we can agree indeed that the reasons for not stopping the trial are obvious EVEN with a STOP advice.

SUNRISE reasons to stay in, WHY did they STOP it so easy?

1) Bulk of trial PAID for, all patients were enrolled.
2) Only a few months remaining treatment of last enrolled patients.
3) They could have gatherer much more data by letting it run
4) Second Look-in only 3 months away, they could stop it there.
5) How was 1st look-in set in Q1/2016 without the OUTPERFORMING info?
6) Bavi arm separates late, PPHM knows that it needs more time
7) 33% events, WHY ASSUME that the 66% others WILL ALSO OUTPERFORM ????

So I agree they took the STOP because they WANTED it because they had plenty of reasons to let it continue. That is why I proposed two different theories here that could be WHY PPHM steps out of SUNRISE so easy.

Highest MOS for control arm 10.4, Herbst 9.9 and Opdivo Alone 9.4.
PPHM added margin, so I guess they at least took 12+
Curious how much dramatically means.

PS: remember PPHM could stop a trial at ANY moment, without look-ins. Only the look-in gives them a letter from the IDMC with an advice that they can use as the reason WHY they stopped it. Who will say you shouldn't follow an advice of the IDMC.

So there is something else going on.