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 : Biotech Short Candidates
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Robohogs who wrote (834)4/25/2007 12:08:19 AM
From: Robohogs   of 897
 
Some quick comments on AVNR:

1. $160 MM market cap (better short when it was $250 MM)
2. $9 MM of cash with burn rate of $10+ MM per quarter (Company says $20 MM over next year while conducting new PhIII(s)) and $25 MM of debt.
3. Ph III doses for neuropathic pain were either 30 mg of quinidine with 30 mg of dextromethorphan or 30 mg of q with 45 mg of d. The doses used for IEED were 30 and 30 and resulted in approvable due to safety concerns. Incidence and severity of side effects supposedly similar per the Company in the NP and IEED trials. Have not gone through QTc effects from the NP trial. But why would FDA approve for NP while sending it back to a 2 year (per management) trial for IEED?
4. Does testing with smaller doses of q and/or d even get rid of safety questions? Approvable would suggest you should be able to but what is reality?
5. Ph III for IEED will use 10 mg of q vs. 30 mg. They may also lower d due to its side effects (nausea, dizziness, vomiting). This sounds like one of those poorly defined Ph IIIs with no reason to know if dosing will work.
6. They did have SPA on NP so efficacy "should" be ok but only have reported that it was significant vs. placebo. Did SPA have 2 trials?
7. For IEED, AVNR thinks it can do a 3 month all-comers trial to answer all the questions in the approvable. But they still do not have the clear path forward.
8. Approvable for IEED did include questions about efficacy.
9. High burn due to AVNR commcl infrastructure and acquisition of Alamo with its salesforce.
10. Other drugs from Alamo include oral ED, oral hypnotic and a drug for candidasis.
11. Is there anything in AZD2479 (reverse cholesterol transfer) which was returned by AZN?
12. AVP-13358 for asthma and lupus is halted currently.
13. AZN and Novartis collaborations ending. No new revs post Q3.

Jon
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News