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Wednesday, 11/25/2015 11:10:14 AM

Wednesday, November 25, 2015 11:10:14 AM

Post# of 345605
I've been poking around the intro section looking for the transcript info where I remember Dr. Garnick laying out in long boring detail how he expected the Sunrise trial and BLA submission process to proceed. In the process of doing this I came across some interesting info that I think is relevant to discuss at this time. But before I get to that I'd like to ask anyone if they have a transcript of the 2014 annual shareholders meeting. The link in the intro box that CJ has leads to a webcast archive that is no longer available. I would greatly appreciate it if anyone who has search capability for old posts could track down a text transcript of that meeting,

Now regarding the interesting things that I've seen during this search.

First this is from an intro section link of the 2014 ASM that consolidates poster reports from people who attended the 2014 ASM:

By: Um-Tiger 10-16-14 8:57amET iHub #194227
• From what I understand, enrollment is more like a bell curve than a hockey stick. The inflection point is now with 145 sites up and running. 160 is their goal in case some centers don't enroll. It slows down when they get over 500 patients b/c they don't want more than 600 patients so it would end the bell curve. King & Shan are visiting some of the sites. Not all but as many as they can. Most if not all of the doctors said they have never seen management visit the center. It was encouraging. They are trying to enroll as fast and as many as possible. There are 2 look-ins next year. The first one is in the Spring and it is to see whether the safety and efficacy is good. Basically, a Go/No Go. The 2nd look-in will be Q4 2015; that will be about stop the trial (MOS & P-value) or continue on. The trial will end around Dec 2016. All of this depends on the enrollment and how quickly patients; sadly pass. So, we are 13 or 26 months away from seeing results.
• Ebola was talked about a lot. The PR yesterday was worked on/submitted back in February and now it is out. Not holding my breath; but something could be brewing for Ebola. Money is there from Gates, Zuckenberg and Gov't since it is becoming a national crisis. Need to combo like with interferon or something similar.
• Liver & Breast papers are coming from the doctors... Yopp & Allison Stopeck soon. In order of importance are Lung, Breast, Liver and Melanoma trials. Liver could leap frog breast if results are really good. Liver is encouraging and wouldn't be surprised to see an Asian partnership for Liver cancer. Not holding my breath but seems to be the best bet at the moment.
FU/194234: No...it is all event driven. I guess I should say they are guestimates on when the look-ins will be from management. They will PR when enrollment is complete and that is it. No half way or ahead of enrollment PR, just enrollment is complete. Just said enrollment is going good and they expect it to be complete by end of 2015. King & Shan visiting they believe has helped enrollment.
FU/194772: The dates to focus on are Dec2015 and Dec2016. I spoke to SK and he said the 2nd look in would be in Q4 of 2015. He was not holding his breath, but would love to hit jackpot. He was focused on Dec2016. He also said if Dec2015 came back at p-value 0.05, they would probably let it continue on. P-value would have to be significant lower than 0.05 to stop the trial. He is focused on Dec2106.


I was going to discuss the implication of these statements (especially in regards to Steve King consistently saying the enrollment was on track) that were underlined but as a kept reading the entire content of the link provided above I came across what appeared to be conflicting information regarding what was said about the interim look-ins. Therefore, I will just suggest that you review the information in the link (the reports begin below the slides in the link), I believe I lot of you will find it very interesting. I'll leave it at that.
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