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biopharm

10/25/16 5:15 AM

#277154 RE: Protector #277153

CP, regarding the non-blinded data being combined with blinded data...I wonder if it would be possible if later they somehow find a biomarker within the blinded data alone and no need to combine with the non-blinded data ...IF that would make a difference to be used to file with the FDA ....but I still think no matter what, that this all has to do with allowing some new partner have their wish with whatever combo best suits them.

Anyhow... I have a little theory regarding the LinkedIn initiative to "close the door" so to speak on being able to view all those that follow a company and remember, in a world of transparency where Facebook meets LinkedIn and the goal is to let the world in to view all....this closing of the door to seeing followers never made sense to me.....

But I do see that "Reid Hoffman" CEO of LinkedIn was supposed to be the primary 10% outside investor of Facebook and he turned it down and referred Sean Parker to his friend ....guess who??

Peter Thiel

I have some new theories now and all these billionaires in the room making me think they certainly are not going to just let PS Targeting pass them by and a coincidence that Peter Thiel gets in with Robert Garnick at Stemcentrx

eb0783

10/25/16 9:21 AM

#277168 RE: Protector #277153

AVID II was 6 months late and while I have no problem with that given it was a brand new innovative technology. I therefor think that AVID II experience allows to set-up AVID III in less time and avoiding whatever it was that delayed them.


I agree with you that the next facility, which in most ways is a cookie-cutter design of Avid II, should go in quicker. Also like you and most of us, we are most concerned with when it will produce reportable revenues. Avid II was announced in December of 2014, I believe. Construction started sometime during early 1Q15. I and two others toured the facility in October 2015 and it was running test batches. We toured it again two weeks ago and the tour leader told us it had been in commercial production since the previous quarter. Since they report quarterly and since they had some 3rd party testing backlog/issues this last quarter, it has been over 18months and we still have not seen $$ reported from the new facility yet. ....NOW Avid III has not begun construction yet. So I am at a loss as to when it will contribute revenue.

So I am not worried about AVID III implementation time table but about the communication of when it is up and running for paid for activities. Running PAID FOR test batches that are specific BEFORE start-up of sales-grade product for 3rd party customers DO QUALIFY to me as production from an AVID perspective because the customer pays for it.


Wernaaa

10/25/16 3:58 PM

#277198 RE: Protector #277153

Means no BLA....and again botched like the PHII

Again a loss of trust....but it's PPHM....

From 10/12
It is my personal believe that PPHM will adjust the BLA filing to get approved for the 30% of ß2GP1 identifiable patients and that they will not file for the complete target population because Sunrise didn't confirm PII for that population due to the over-performing control arm. I do however NOT exclude that they'll file a BLA for it ones it is established what the cause of the out performance was and depending on what provision Dr. Garnick has put in the FDA approved Sunrise protocol as PPHM has disclosed.