Rick,
Regarding your #1195 post, my heart always skips beats when I see posts from you! :)
Nice news, and a little sooner than I had expected. I figured we either would hear before or after the holidays, obviously, but not this week. Getting on the panel now allows atis to rest a bit more comfortably other than wondering for sure what the fda will say, and then getting on their horse in preparation for the rollout, as if they're not already doing this...even though with a panel recommendation there is no way to see just how quickly the fda itself will finalize a decision. Think we've already talked this subject to death over the last year plus.
Regarding the "optimize the therapeutic range," just repeat this name after me.....Eric Hecht. Remember toward the end of '96 when ATIS was downgraded for what was described as retrospective analysis? Generally, atis had started the dermagraft trial and fine tuned the patients as time went toward the dermagraft with the right parameters of matrix factors, proteins, etc. to use the type with the most efficacy, and then referred to their positive results in a large % of their subjects, referring to those who used the dermagraft with "ingredients" within these found better parameters......thus, loosely described as "optimizing the therapeutic range". Since retrospective analysis is generally frowned upon in the scientific community, it cost them some credibility.....in other words, anyone can figure out results and manipulate data after it is already in, and then skew them from there. The result was downgrading and delays, such as needing to do a confirmatory study which used patients being treated with dermagraft which had its "ingredients" only within these specific parameters(optimized therapeutic range), with the purpose of proving that this product is actually effective, etc. The risk here was that the results needed to not only be positive, but similar to the results seen in these patients in the first study, or else they would have to explain why the different findings....but all worked out, and I found atis to be very forthright along the way with where things were rather than playing games.
For those who read between the lines, it was clear that nothing had actually changed within the company or the product potential...only image(such as with upgrades/downgrades) was affected, other than the obvious negative implications about delays with the fda process. Analysts stated that the % s for improvement in the first study weren't really all that good, etc., and gave numbers for all of the subjects rather than for just those who used the dermagraft which was within specified biological parameters, and as such actually either manipulated the public or simply didn't understand the data or trust what atis was telling them. Retrospective analysis can have different meanings for a whole new area of science such as tissue engineering, and without other forms to really compare with, some other forms of analysis likely will be very helpful along the way. This whole issue is what caused me to be annoyed at how E. Hecht dealt with the whole thing. I can understand why people who needed money quickly sold, but for people to jump out from their "speculative investment" because they thought something had really changed didn't make sense.....this is actually what gave many investors excellent opportunities to purchase more shares from 8-11 for some time, primarily toward the end of '96, as timing of the downgrade "coincidentally" occurred at tax selling time and further drove down the price, leading to a quick rebound in january.....so even with poor biotech performance, if you bought on 12/31/96 at just under 10, you would still have had good performance this year, even with the recent drop.
In other words, ATIS wants to fine tune the cartilage to what looks to be the best specified parameters of its ingredients, which would be somewhat time consuming, before starting their clinical trials, and thus avoid a repeat of the above described events...ultimately would speed up the process if no confirmatory studies are needed, etc.....however, it will all only be expedited if they don't take too long to get it going......my preference would be sometime by the end of the 3rd qtr at latest, or it probably defeats the point, as they will have created their own delay and possibly pick their own way of interfering with their credibility...although getting dermagraft out will help with the credibility factor a bit! As far as I know, S&N is just as much their partner with cartilage as they are with dermagraft...50-50, with possibilities of milestone payments and loans if needed.
Truly it looks like ATIS is focusing most of their energies right now on dermagraft while quietly behind the scenes figuring out their approach toward the cartilage trial without feeling the urgency for it that I would prefer. However, I am not feeling uncomfortable with my investment at this time. My guess is that as word gets out, either with the placement on the panel agenda, or definitely if it gets the recommendation, that analysts will start changing their tunes or joining in with buy recommendations....we shall see. FWIW, it was interesting how quickly Hecht upgraded in '96 and then downgraded very quickly thereafter, and has generally been quiet since, at least regarding atis. He is a knowledgeable analyst(not always a paradoxical statement!), but nobody can follow everything perfectly all of the time.
Happy days,
Marshall |
