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 K. who wrote (6582)6/25/1998 8:15:00 AM
From: Robert K.  Read Replies (1) | Respond to of 17367
 
Repost of my yahoo post>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>>rBPI21 is several things going for it with the fda
1. First biological to get subpart E status.
2. Orphan drug status which infers priority review.
3. Novel antibiotic-which infers priority review.
4. Small market which infer faster review.
5. Meningo-kid killer>-infers priority review.
6. rbpi21 seems very safe (so far)-infers faster review.

And SLgonzales is correct-fda is being more lenient on off-label claims and marketing. If a approved drug can show some scientific premise to use it off-label, then can be presented to physcians by the drug company. It is up to the doctor to decide
to use it or not. Previously the drug could only be marketed for
"proven" indications. All else was disallowed.
NOW (if above is true) ..>
rbpi21 has many,many,many citations for possible use in many,many indications (see my note 945-which is outdated).(yahoo945)
This vast data will encourage off-label testing by doctors in vivo.
All disclaimers always apply to all my notes. Consider all as opinion and none as fact.



To: Robert K. who wrote (6582)6/25/1998 10:40:00 AM
From: Alex Glavinos  Read Replies (1) | Respond to of 17367
 
Robert K, Thanks for your informative posts. They are greatly appreciated. Alex