SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: Robert S. who wrote (8366)1/19/1999 10:34:00 AM
From: opalapril  Read Replies (1) | Respond to of 17367
 
Back to the P-3 issue. Supposing it is true that a specific number of overall deaths in the experimental and control group tolls the end of the study -- a conclusion that I think remains speculative until confirmed by Xoma or the FDA -- it would appear Xoma seriously misled the public. Check out these answers in the FAQ from the company's web page:

Q. How long will it take to complete the trial? How many patients will be enrolled? (6/98)

A. We plan to complete the trial at the end of 1998 (two years from start). The final number of patients enrolled will be the number we have accrued by then.

Q. Why didn't XOMA stop the meningococcemia trial at 200 patients? (6/98)

A. The original Phase III design agreed to by the FDA called for a two year trial. Our intention was (and is) to accrue as many patients as we can in two years. * * *

Q. Do you have an estimated date that the Neuprex(tm) data will go to the FDA for final review? (6/98)

A. The meningococcemia Phase III trial is scheduled to complete enrollment at the end of 1998. The earliest we will know results is after the 90-day follow-up period. Assuming the data are positive, we would complete the BLA (Biologics License Application) filing to FDA most likely by midyear.

Now, "scheduled to complete enrollment" and similar thoughts here were very clearly expressed: the trial would be "complete" at the "end of 1998." This seems to me very different from an open-ended termination dependent on specific endpoints or treatment milestones.

Someone suggested I call Ellen. What good would that do? If she prevaricated on the web, why wouldn't she prevaricate on the phone? And if the total deaths business is an invention of Murphy's (I'm still not clear on where all of this talk originated! Can someone please help me out here?) then why bother Ellen with fictions?

No personal offense intended, Ellen. Either way, I understand it's your job and I'm sure you do it magnificently.




To: Robert S. who wrote (8366)1/19/1999 7:29:00 PM
From: Tharos  Respond to of 17367
 
suggests that one would be better served, IMHO, on a risk/reward basis, if one waits until after a possible FDA approval

Perhaps to someone like yourself, who only measures reward in terms of $$ and is impatient if the "chosen" investment does not immediately increase in value. But there are other rewards to be derived from providing venture capital for new processes, new industries, and new people. Doubt you would understand, but I am certain others on this thread do.



To: Robert S. who wrote (8366)1/20/1999 7:26:00 AM
From: Robert K.  Respond to of 17367
 
Commentary>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>>>
>George:
I am also sure that if XOMA does start to take off for the right reasons, you will be able to get on board. It is apt to be a slow moving train.
Robert S:
suggests that one would be better served, IMHO, on a risk/reward basis, if one waits until after a possible FDA approval. This issue has been addressed previously and I applaud you for recognizing the obvious.
RobertK: Obvious? We WILL see how obvious soon enough. :-)
All IMO