I have a somewhat different view on IMUL's latest trials.
The problem here is the high placebo effect. Allervax Cat works well, and as Lyle pointed out, the higher the dosage, the stronger the effect. Unfortunately, in certain cases, the placebo also worked. IMUL says that one reason for this is that patients may have come into the trial with high expectations given the Phase II results. Even still, the results for the 2x2 trial (2 doses per week for two weeks, 750mg) were unequivocally better than the placebo and clinically significant as well.
It's noteworthy that the four analysts who have buy recommendations out on IMUL all reaffirmed their buys after the Cat data came out.
The stock price fell, in my opinion, because IMUL is almost certainly going to have to run this trial over. The sample size for the significant group (45) is probably too small; IMUL was hoping that both 750mg groups (2x2 and 1x4) would be significant so that it could combine the two, but it didn't work out that way because of the placebo effect. If the FDA makes IMUL re-run the trial (we should know this by June), this will set IMUL back about 6 months. Instead of filing a PLA by year end, it will be mid-1997.
HMR didn't know these results in advance, so again I don't believe that HMR gave the Allervax line back to IMUL because of poor results. If HMR really was interested in Allervax but was suspicious of poor pending results, why wouldn't it have simply waited until now to give the product back? It's because HMR is shifting away from autoimmune biotech products in general.
Did anyone see the recent article on Amerindo Management in last week's Wall Street Journal? They were profiled in the WSJ because they have the best 1-year and 5-year management records for all money managers. They are IMUL's single largest shareholder and they recently bought more stock on the HMR price decline. I believe they are up to 16% or so. Unfortunately, while the article mentioned that Amerindo has big holdings in biotech, it didn't specifically mention their IMUL holdings.
Paul |
