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To: Dale Baker who wrote (4487)4/18/1999 12:56:00 PM
From: SteeliejimRead Replies (1) | Respond to of 118717
 
Good morning:

There are actually some pretty intelligent posters on theANIK thread. We collectively blew it re. the FDA approval probabilities last OCT. I don't think the co. was forthcoming enough in July when the approval was first supposed to occur. If you want to wade through the postings there are some reasonable guesses as to the time table. I tried myself in a Yahoo post after the collapse in Oct.in providing rationale why I thought it was going to be dead money for at least a year. (don't remember the #), but even recent guesses were along what I thought at the time--namely 6 to 9 months for the study (FDA just approved protocol so study is just starting), another 3 for results analysis and packaging, 3 to 6 months for approval.

My guess now would be Dec. to Feb. but I may be overly pessimistic now. The stock will move earlier in anticipation--a classic buy on rumor, sell on news IMO. I would suspect that people (like me) are watching to see when volume starts to increase to do a pre-approval play. That could start any time, but probably not for another few months.

There is another wrinkle, and it's best to look over at BXM, a competitor on which I made a nice profit a few months ago when they got their US plant approved. There is a short battle going on based on the contention by the shorts, who are being very public (expected) but are also logical (unexpected) citing slowing sales growth numbers and possible channel stuffing.. On the surface BXM sounds like another possible Safeskin (another possible value play by the way--SFSK. I did well in that one too before the collapse--I got out at 39 right after the peak. A lot didn't).

Anyway, while many are touting the HA treatment for knees as great relief (with a number of studies and anecdotal support), there is a campaign to sow doubt as to the real size of the market and to play up competition from the new anti- inflammatories. Based on my experience in BXM, it appears to have dynamite management with very responsive IR and is scheduled for a 2:1 split. However, the shorts are sounding credible enough, even getting an opinion piece in TheStreet.com, to scare me off for the moment . The BXM Yahoo board is relatively quiet but has some of the nicest bunch of posters I've run across. I wish BXM and them well.

The gist of ANIK's problem originally was that some of the patients had two bad knees, were tested on only one, and did not see much improvement. That is apparently why approval was not given in July when first expected, but ANiK was not fully forthcoming IMO. When that data was thrown out, there wasn't high enough statistical significance in the remaining number of patients to suit the FDA. Frankly I'm surprised that there was not a share holders suit brought against ANIK--there may be yet.

Jim