You are trying to get some crucial information about ZILA.
I think that you have to start at Investor Relations at ZILA. It is not completely clear to me which of the 17 CEDR advisory committees would have jurisdiction over the diagnostic. I tend to think it would be the Oncologic Drug Advisory Committee. ODAC is extremely busy, and this could be an innocent explanation for the delay. IR at ZILA can at least tell you which commitee it belongs to. If you are fortunate, IR may be able to tell you a lot more. For example, IR at DEPO told me and I told this thread about the ODAC committee meeting on DepoCyt more than a week before the company made an official press release.
If IR won't tell you something meaningful about the status, and you know the advisory committee, you can try contacting the advisory committee. I would guess that they won't tell you anything except that "we announce the subjects of committee meetings to the public 30 days in advance of the next meeting", but again, you never know until you try.
Another source would be the analysts who cover the company. I have found them to generally be a wonderful resource at biotech conferences (if you go to them).
Another way might be if you have a full-service broker, but I don't have any of them, so I am really not sure how much one might be willing to help you.
Here is some info about the FDA's CEDR:
Drug Information Branch (HFD-210)
Division of Communications Management/OTCOM
FDA/Center for Drug Evaluation and Research
5600 Fishers Lane
Rockville, MD 20857
(301) 594-1012
Fax: (301) 594-3302
E-mail:dib@cder.fda.gov
You might also consider selling your position and buying again when a definite date has been set. For example, if you look at the CGPI thread in recent months (its only about six postings) this is what I did with CGPI when they became inexplicably delayed with the FDA. I sold out. These biotech stocks so often sell off after good news, that it makes me wonder whether or not there is enough return to justify the risk involved in owning them while waiting for some decision or event. I'll buy it back when they have approval and I have some spending money again.
Hope this helps,
Tom D |
