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To: DaveAu who wrote (8569)	1/28/2002 10:20:06 PM
From: axial	Respond to of 14101

"It does raise a question however about the competency of the Oxo Chemie staff that were responsible for overseeing the trial." Yup. Let's hope there are no surprises in that closet.

To: DaveAu who wrote (8569)	1/28/2002 10:45:38 PM
From: john.d	Read Replies (3) \| Respond to of 14101

bluejay said: ". That's another way of saying that the blind has not yet been broken. And that is actually very good news." Dave, it is my understanding that the data has NOT been unblinded, which is based on a conversation with Renny HO late last fall. When Mark asked the question about dimethaid looking at the data at the AGM, BEcky danced a lot and suggested they had seen something. What I concluded from all this is that Dimethaid may have seen some of the overall results, but does not know which is from the test group and which is from the control group. It may have been that there was some patients doing much better than others. As you point out they really aren't risking all that much at this point. I guess the other point, Dimethaid has invested a substantial amount of time and money so far that they have to see it to a conclusion. At this point, you can't just walk away from a potential drug of this nature even if you believe the results are going to be below your original expectations. IN any event, the picture that appears to be emerging for me is that the Oxo work MAY not have been as well managed as I think we or Becky expected. There is very little Becky or anyone else can do at this point, the planning, organization, performance contracts, test protocols all needed to be properly done long ago. Not that I'm saying they were not done properly just saying that there is a limited amount one can do at this point. Or put another way the "Queen Mary" set sail from port long ago and you can't change where you're going and who's coming along for the ride now that you are coming into port on the other side of the ocean. I listened to the CC and to me Becky was not as upbeat as usual and didn't say as much as I expected about FDA. Anyone else have that sense? I have been concerned that the large draws of late may be signally some more bad news ahead. Pure speculation on my part and I consider this to be low risk possibility. After 5 years and still waiting I can say that I am thoroughly worn out. John

To: DaveAu who wrote (8569)	1/29/2002 12:34:07 AM
From: Cal Gary	Respond to of 14101

Good evening Dave and Joe, Joe, I'll have to go with Dave on this one. <g> LOL Thanks for the clarification. I am in agreement to get it right. Perhaps the best wording would be 1. "DMX 'formally' announced July 18 to acquire OXO 'as soon as ... the last patient was enrolled and the Phase III closed." 2. <<nothing speaks louder about the phase III results than the fact that DMX announced their intention to buy Oxo as soon as the [blind was lifted] last patient was enrolled and Phase III closed, then announced several months later (after doing their DD) that they were going ahead with the deal.>> So when exactly does the Phase III become unblinded? When the database is locked or when it becomes known which patients are in the placebo group or the WF10 group? When its published? ---------------------------- Clippings I gathered from my searches and post from SI may have contributed to my understanding of unblinding: And I posted twice, once in May then in July: "di7026 (ID#: 38005) WF10 AIDS TRIAL 5/24/01 07:52 3646664 As confirmed by Dr. Pugen, the Phase III trial will break in the third week of June. We should expect info concerning the data some time after that." di7026 (ID#: 38005) RE: UPDATE 7/9/01 15:13 3861861 "When will they unblind the phase III trial?" As I had posted before, Dr.Pugen of the www.wf10.com has informed me that the WF10 phase III trial was unblinded at the end of June, 2001. But gathering and analysis of data will take some time." bluejay (ID#: 36864) WF10 results Expected Date - Repost 7/28/01 10:29 3944240 « Previous Message Next Message » Just to clarify the expectations, below is a repost of an e-mail response I received from Oxo on May 30 (bolding is mine): we are expecting the last patients to complete their review period by the end of June, early July. Once the last patient has officially finished the study, the complete collected data will be analyzed and a report prepared. This usually takes from two to four months, after which the results will be made public. I thank you for you interest in OXO Chemie and especially this important HIV trial. With kind regards, Daniel Kuehne Project Manager

To: DaveAu who wrote (8569)	1/30/2002 3:40:03 PM
From: Joe Krupa	Read Replies (3) \| Respond to of 14101

Dave, "I appreciate all the info you two have provided on this board. I think you're two of the most valuable posters. I also think you've both picked up some serious mis-information about the WF10 phase 3." First off, thanks for the complement (blush). On the issue of the unblinding, I now believe you are likely correct. I've done a little rehashing of the process in my mind, and have also solicited the opinions of a few other posters who's opinions I much respect. My conclusion is that the blind is likely still on, and given Rebecca's comments in the CC this is likely a good thing. However, I still stick by my belief that Rebecca had a pretty good idea as to the likelihood of success when the trials wrapped up. Just my opinion. joe