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Stone, re your post excerpted in relevant part below:
Sunstar, re your post below excerpted in relevant part:
Cheynew, re your post excerpted in relevant part below:
Hello again Ent, re your response excerpted in relevant part below:
Hello again Ent, Regarding your recent post excerpted in relevant part below:
hopefilled, Re your final question highlighted below:
Hello Ent, I think we've touched on this topic before - the following is excerpted in relevant part from your post to CJ:
Sunstar, I think you may be correct in both assertions.
But re your first - Highly positive PR's don't normally come out on a Friday - but perhaps tomorrow will be the exception - as ASCO gets underway.
We'll see : )
James
Bio, Interesting speculation per your post below - and most definitely not "wild.". However, enrollment of the first 18 patients would actually only take three weeks - as two patients per arm [or six patients} per week would be enrolled - so the initial enrollment was likely completed prior to the Sunrise halt - which means the data has likely been available for at least sixty days.
James
IFU, re your post excerpted in relevant part below:
Bungler, re your comment:
MH, Good to see you back.
If you'd like to share, I'm sure everyone would appreciate hearing your insights on PPHM's current status.
Hope you are well.
James
CJ, JJ, et al, Thanks for running the actual facts up the old flag pole one more time : )
Ku, re your post:
Volgoat, re your post concerning Dr. Garnick:
Volgoat, you may want to rethink your statment:
CP, good post - I actually did LOL : )
jq, re your post below:
vin, re your post below:
exwannabe, re your post excerpted in relevant part below:
jq, re your post excerpted in relevant part below:
Volgoat, re your post below:
jq, re your post excerpted in relevant part below:
oldberkeley, re your post below:
CP - nice analogy.
Very easy for ALL to understand.
jq, re your post below:
Exwannabe, Well then you may get your wish quite soon - I'm told Dr. Garnick's mood has greatly improved these past few days. I wonder what's up?
md, the review is ongoing - it is being conducted by Dr. Garnick. PPHM has told us that there will be a complete review of all of the Sunrise data and the results will be released in full once Dr. Garnick completes his review and analysis.
As I believe CP recently mentioned, Dr. Garnick will likely play a central role on the next CC.
md, PPHM - meaning primarily Dr. Garnick - has stated that they are reviewing all of the data and will provide a full report once they complete the review. It should be forthcoming in the not too distant future - although it will likely be presented to the FDA first.
Cheynew, thanks for your response excerpted in relevant part below:
I don't think it matters much if you or I - or anyone here actually - agrees on the definition of what constitutes an "impressive" result. As of course it is only the FDA's opinion that really matters - and it appears - judging from their very recent actions - that the FDA believes a 12.2 month MOS in NSCLC is indeed a VERY IMPRESSIVE result.
So logically - if Dr. Garnick can show that the Treatment Arm in Sunrise surpassed the FDA's recently set bar for what constitutes an impressive result in NSCLC - be it by only a few weeks or more likely a couple months - then Bavi will indeed be demonstrating very impressive results that the FDA will likely find very hard to ignore.
Cheynew, a question regarding your statement below:
Hello Ent, a question related to your post excerpted in relevant part below:
CP, regarding your post as excerpted in relevant part below:
Volgoat, Well, I guess you don't intend to actually respond to my question. So how about if I put a time line on the question - lets say AZN wants to preserve exclusivity as an I/O combo in NSCLC - as of course they need some way to vault Durvalumab past Opdivo if they hope to erase the lead BMS now has in this arena - and they believe - as Dr. Brekken has aptly illustrated some time ago - that bavi may be the best candidate with which to combine to achieve this goal - and as such, they make that first $$$ deal with PPHM sometime in the coming weeks.
So, what happens?
Volgoat, excuse me - but I don't think you answered the question.
Volgoat, re your post:
CP, Good question.
James
CP, Bravo !!!
jq, re your comment to CP's post below:
Chey, in response to CP you posted: