Thomas Wei of Jeffries, who at FDA did he talk to about ARNA and its data prior to Adcom?

Who did "Thomas Wei" talk to at FDA about the data and statistical analysis? What info did he have before hand? Did Jeffries sell in the first minute after Adcom documents were released?


Very interesting posts

By Avo

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=105047&mid=105047&tof=1&frt=2

PART 1 From http://online.wsj.com/article/BT-CO-2010... “Jefferies analyst Thomas Wei conducted an alternative analysis of available data and believes that Arena's data doesn't rule out heart-valve risk to a level wanted by the FDA. He said he believes his method will be preferred by the agency over the company's, citing two guidance documents from the agency and feedback from an FDA consultant statistician. Wei has a hold rating on Arena's stock and lowered his price target to $5 from $6.” ARNA has already said, “The integrated BLOOM and BLOSSOM echocardiography data set rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Echocardiographic evaluations showed no association between lorcaserin and the development of heart valve insufficiency. Rates of new FDA-defined valvulopathy in BLOSSOM at Week 52 were as follows: lorcaserin 10 mg twice daily (2.0%), 10 mg once daily (1.4%) and placebo (2.0%). "The echocardiographic safety data show no risk of valvulopathy," commented Neil J. Weissman, M.D., Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. "In the individual and combined BLOOM and BLOSSOM data sets there is no evidence of a difference in the development of valve disease in lorcaserin patients versus control for up to two years of continuous use. No prospective echocardiographic program has ever studied this many patients for this period of time."” Why would ARNA’s method of analysis be in doubt? Since Wei hasn’t revealed what the difference is between the two methods, we’re left to speculate. Some of that speculation (certainly from my end) has been that Wei may be thinking the BLOOM and BLOSSOM data were not meant to be pooled, that the FDA wanted each trial to reach 80% power on its own. (The NEJM article stated that the BLOOM trial only reached 60%). However, ARNA has repeatedly stated that they will pool data from BLOOM and BLOSSOM in order to meet “the prespecified statistical criteria that allow [them] to declare lorcaserin to be non-inferior to placebo for development of cardiac valvulopathy.” What is that “prespecified criteria? “The FDA previously requested that Arena rule out a 1.5-fold or greater risk of valvulopathy with 80% power.” So can they pool the data to meet this criteria or can’t they? Was that the original intent or wasn’t it? Did they not decide to pool the data until after seeing that the BLOOM trial only hit 60% power? The data will be pooled and the FDA will have no problem with it. Below are some statements from past conference calls that appear to put this question to rest (caps emphasis is mine, obviously). From the Q4 2008 Conference call: Bret Holley, Oppenheimer: “Jack, I was just curious about your comment about looking at multiple data points from pivotal trials. Am I reading too much into that in regards to the partnership process? It sounds like if you are going to be looking at multiple data sets, it would certainly suggest that a partnership might be on a timeline behind the BLOSSOM results minimally. Jack Lief (CEO): “Well, in partnering you never know for sure. If it was confusing, I apologize, but the multiple data that I was referring to was on the valvulopathy. There are two studies that are needed to fully address based on the way we power the studies addressing the FDA guidance to rule out valvulopathy and obviously there will be a lot more information. We haven’t unblinded the studies yet, so we don’t know the full results, but there will be a lot more information about that in a couple of weeks, SO WE’VE AGREED WITH THE AGENCY THAT BOTH THE BLOOM AND BLOSSOM STUDY WILL BE ABLE TO POOLED FOR THAT VALVULOPATHY ISSUE.” (emphasis added) From the 3/30/09 BLOOM Trial Results Webcast: 55:40, Carol Werther, Summerstreet Research: “Do you definitely need the BLOSSOM results to meet the FDA . . . to rule out the 1.5?” Christy Anderson, (VP of clinical development): "The agreement we have with the FDA is to have sufficient statistical power to rule out this 1.5 relative risk with a power of 80%. We’re not quite there with the number in the BLOOM trial. We will combine the BLOOM and BLOSSOM data and will have more than enough patients to satisfy those FDA criteria. Considering how large the BLOOM trial was, how many thousands of patients we have examined, we think it’s probably pretty accurately predictive of what we’ll see in BLOSSOM, so WE ANTICIPATE BEING ACTUALLY SUBSTANTIALLY OVERPOWERED TO ADDRESS THE AGREEMENT WITH THE FDA REGARDING THE VALVULOPATHY.” Here’s another encouraging comment from Jack: 103:55 Matt Osborne with Lazard: “Can you remind us, Jack, what you expect in terms of labeling for lorcaserin. Do you expect a requirement for screening for valvulopathy or no requirement at all upon getting a final label?” Jack Lief: “Obviously labeling is important. We expect that the data will show that there’s no reason to require screening. THE FDA ALLOWED US TO NOT REQUIRE SCREENING IN THE BLOSSOM AND BLOOM-DM STUDIES AFTER THEY SAW THE SIX MONTH DATA REPORT FROM OUR ESMB IN THE BLOOM STUDY. The BLOOM study also shows that even over a long period of time there’s no signal whatsoever in valvulopathy so there’d be no reason to screen patients, so I’m excited about that.” What, then, is the difference between ARNA's method and Wei's method? The fact that he hasn't revealed what his method is renders his motives suspect. I think we can just about put this baby to bed.    By Johngray on YMB - He posted his letter to Thomas Wei, http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=105146&mid=105146&tof=2&frt=2 Sunday, August 15, 2010 6:41 PM From: "John Gray" <johngray101@yahoo.com> View contact details To: twei@jefferies.com Thomas Wei, You make a very strong claim, please back-up your data by posting it or please e-mail the information. If your data is true then you have nothing to fear, but if your data is false when it comes to light on 9/14/10 when Arena pharma provides documents and stats otherwise. Especially at the AC 9/16/10. You'll have a ton of people reporting you to the SEC for false and misleading information. see link: http://online.wsj.com/article/BT-CO-2010... http://www.benzinga.com/analyst-ratings/... You make a very strong claim, please back-up your data by posting it or please e-mail the information. Thank you, JG