"pIII trial progressing well" ...not bad, this is the only value in this company at the time, unless one wants deep and prolong hibernation waiting for the rest of the technology.
"third indication soon" ...is second kidney transplants? then one more coming, the third? not bad.
"Mr. Castello says that although FDA found data "very compelling," FDA wants more data." ...here again with the non scientific emotional talk that protects from lawsuits, yeah compelling enough to reject and ask for more data, of course it means more trials, or finding the floopies the dog ate.
Which data is missing they could not find in 9 months of analysis? NONE, is back to trial, clearly imply in the reference to "seasonality" "next fall winter" "no approval THIS YEAR"...
"other drugs have gotten through on subpart E
without good (or any) p-values," is this an indication of lack of reasonable ps? (sorry, I learn this with Gw),
but, if one more on the subject,please check my recent post about two drugs approved in May/2000, they do have compelling data and good ps.
"Mr. person and the rest of the board are good people"...yes, and we are all going to disneyland courtesy of Bermuda's Pinksands, ltd.
"FDA can still kill the drug. This evidently happened with one of Xoma's prior drugs--drug got a 7-1 vote in favor of
approval from subcommittee, but got flushed by FDA nonetheless." ...reccomendation for approval by advisory comitte is non-binding to FDA (good, so We do not get much garbage out) and E5 (yes, Pfizer) DID NOT WORK, full data is already published long ago, medline and main article previously post in this thread. At least they have plenty of pain to cry about, they are still crying the E5 one (like Prohost lingering sorrow).
ncbi.nlm.nih.gov
talking ps, look at the number 0.01 it is good, but not previously planned for, it was an after trial finding, and reading full article is clear is poor, but the main outcome in main data is clear in the abstract, no statistical difference, compared with recent data from Icos pafase, striking difference. Icos did not wait from no peer review, they went right to public relations, the same place xoma would have go with compelling data. Yes, a major journal excuse, give me a break. All data is now being share as early as possible, check recent E coli discussions, all because THE major journal NEJM allow it to go out before press.
Bluegreen, Why not now, and yes for $2? Well, if one is willing to tolerate the gyrations up and donw, at least one shuld pick this one very cheap, best should be $1 (for the actual cash, before it melts), but $1 cash, and $1 of hope, with decreasing cash will be $2 of hope, then one could tolerate going long for the DNA drug prospect (18 months at best), in the meantime my bet is in DNA and BGEN, and will achieve same, double or triple my money, very low risk. Even Bax is better choice.
But, if one wants plain risks xoma is EXCELLENT. |
