Herb:
Way to go with Calgene. You are correct. Wall Street time line is yesterday while biotech time line is next year, or maybe next year, or maybe next year. Anyway, as I correctly predicted the gap between 3.5 and 5 is already being filled. I pressed Susan yesterday about the FDA regarding the Ragweed vaccine. I asked her if the FDA gave them any indication what it would take to win approval. I also asked her what % improvement in symptom score is generally found with drugs like antihistamines. These two questions are critical so let me spend a moment enlightening everyone.
First, The ragweed vaccine is IMUL's lead product. They must test it during the ragweed season which begins around July. Imul will be using an eight shot regimen of 250 ug/dose and then follow patients for "symptom score" for eight weeks through the ragweed season. In their last trial the ragweed vaccine showed an ~31% improvement in symptom score when compared to untreated patients. When compared to placebo treated patients the ragweed vaccine showed a 17% improvement, which indicated that there is a significant placebo effect from the inject alone. The next trial will have a placebo group and the 250 ug treated group, but Susan was not sure if an untreated control group would be included again. The FDA should be satisfied with data that shows statistical significance like the last data, but there may be other concerns that bias the FDA against IMUL's technology, like clinical relevance. In other words just because IMUL's vaccine shows a 31% improvement, does that really mean that patients benefit clinically from the drug. Maybe a patient only "really" feels better when they acheive a 50% improvement? If the FDA gets into this, then IMUL is sunk because this is a difficult argument to get around and almost impossible to design a drug trial to address. If the FDA gets into this, then the FDA is way off base(IMO) and IMUL may appeal a decision, but as we know time is money. I have heard that there are a number of FDA reviewers that want every i dotted and t crossed by IMUL, which may make life difficult. Nevertheless, we hope that the FDA will be reasonable in its demands of IMUL given that the safety profile of the ragweed vaccine is excellent and that the FDA's input was included in the study design.
Second, what symptom score improve do other allergy afford? Susan told me that other drugs like antihistamines were tested over a short time period, like several hours, because they are not immunotherapy. So we cannot really compare changes in symptom scores. Once she told me this it was obvious that the ragweed vaccine cannot be compared with other therapies (eg. antihistamines, nasal ipratroprium bromide, nasal beclomethasone, etc...). This is both good and bad for IMUL. The good side is that other therapies may be coadministered with the ragweed vaccine and may afford even better protection against allergic symptoms. The bad is that there are no good benchmarks for IMUL to compare the ragweed vaccine to (except maybe standard extract immunization for allegy, which does not work very well IMO). Therefore, IMUL once again may have some difficulty convincing the FDA that the Ragweed vaccine really works. Once again, time will tell, but if IMUL announces another successful trial in January 1998 we may be looking at a $20/share stock with the potential to reach the $30-40 range with FDA approval. Let's keep our fingers crossed. |
