It is a shame that AVNR is trading at this price. Considering your recent move to sell Fazaclo you now should have enough cash to make it for the next year or so. All you need is some partnership for Zenvia for np.
You have no idea how to communicate with shareholders, you have not ONE analyst covering the stock (even in EB's day there were several analysts covering AVNR) and the shorts have had a field day because YOU JUST DO NOT SAY ANYTHING and refuse TALK TO SHAREHOLDERS and your PR is AWFUL.
You have a potential $BIL drug and your company has a mv of $76 Mil.
WHEN WILL YOU WAKE UP AND DO SOMETHING RIGHT.
AM I the only one that owns this stock and is sick as to how things have been handled? Am I the only one pissed off with managements communication skills?
Love to hear comments and suggestions for KK from others.
KEITH, hope you have some good things to say on CC
Do you now know that AVNR is on MSN WORST 50 STOCK LIST!
Does anyone have any good questions for Keith for the CC???
Keith needs all the help he can get.
there are numerous examples of millions of patients benefiting from new drugs in Europe for several years before FDA approval.
1. It would be great for business.
2. It would make the FDA look more closely at the submission.
I hope that The new CEO has Europe and Japan on his radar screen. Huge markets and tremendous potential.
Fingers and other appendages crossed.
"Many times European regulatory approve drugs way ahead of FDA."
"Any possibility this happening with Avanir? Presumably, loads of potential patients needing help there."
...Great question since in the U.S. Avanir has to deal with an FDA with possible post traumatic stress disorder and presumably the ?EMEA? is able to function.
...That said, profit margins are much higher in the U.S.
...Also I have not heard a peep about a New Drug Application anywhere but to the FDA.
...Also, since only one Phase 3 has been done for neuropathic pain, presumably it is only the IEED indication for which a new drug application can be considered presently. I don't know what the rules are for off-label use (i.e. for neuropathic pain once approved for IEED) in other countries.
...Given the socialized medicine that exists in Europe, a somewhat "fuzzy" condition like IEED may not be given high priority when viewed against other conditions that are not funded. Is there still an age limit in England for dialysis for example? I heard (can not believe I heard this correctly) it used to be 65 years old, if you can imagine that. (The alternative to dialysis in someone with kidney failure is death.) Probably would want to fund dialysis for the elderly before Zenvia for IEED.
...I presume Avanir's strategy has been to get the toughest approval first (the U.S.) and then submit the same data to the regulators of other major markets.
...Given the setback with the FDA (and perhaps not for good medical reasons), IF these other countries would allow Zenvia on their formularies for IEED, it might make sense to submit new drug applications for IEED to regulators from those countries but not if this would distract from the effort to get Zenvia approved in the U.S.
...My final thought is that the two Phase 3 studies for IEED were small, only about 140 patients in each one.
So Avanir may be thinking this third Phase 3 will get the number of patients studied in Phase 3 up to a minimum number required for approval anyway and might wait on that account in other countries for that reason as well.
"you have no idea how to communicate with shareholders, you have not ONE analyst covering the stock (even in EB's day there were several analysts covering AVNR)"
The company no longer gives financial guidance during Brandt's tenure. This is a violation of NASDAQ rules.
"Can you find any earnings estimates?
It's rather hard to do so when there are no analysts following AVNR."
...Bottom line is there is enough cash to last until about July, 2008 and the success of the neuropathic pain trial ensures more access to capital when needed.
"AM I the only one that owns this stock and is sick as to how things have been handled? Am I the only one pissed off with managements communication skills?"
...Probably not, but I, for one, am content to wait to hear news as it develops. Biotech R&D doesn't happen fast. Have to prepare oneself to be very patient while reevaluating the fundamentals. Hopefully we will know a little more on 8/8.