To: dino who wrote (2828 ) 1/21/1998 7:58:00 PM From: M. Alexander Read Replies (2) | Respond to of 3906
In this month's Worth magazine, I finally got some idea of what Phase I, II, and III mean. The article is about Alan Carr the pres. of Hambrecht & Quist Capital Management and just states that he (Alan) feels that the three year biotech slide is over and a boom is eminent. But that's not the point. The point is that now I know what the general definition of these trials is and it isn't what I had expected. I thought that the divisions of phases were catagories for safety, efficacy and perhaps something else respectively. But according to Worth quoting Bear Stearns..Phase I examines how healthy volunteers react to a single onetime dose of a drug. Phase II studies how well the drug works on a small sample of patients with the condition in question. And Phase III tests a drug on a large population to confirm efficacy, gauge dosage, and discover long-term effects. There is no mention of nonhuman testing of any sort which I thought was odd but I would think that they would have people breaking down the doors to test a drug in this field. At least for the Phase I they could probably find unpaid volunteers. In fact I am sure that they can recieve many other unpaid volunteers also for the next two Phases which ought to help with the bill. Speaking of the bill, the Bear Stearns estimate is that Phase I takes one years to complete, $9 mil., and has a 38% failure rate. Phase II takes 1-3 years, $22 mil., and has a 40 % failure rate..all averages of course but has some place in the perspective of HVSF, especially I think with the $. Finally Phase III takes 1-4 years (which is why they want to combine the two, I imagine.), a healthy additional dose of $53 mil., and has a 45% failure rate. So it looks like HVSF's plan is rather aggresive hoping to tackle everything by this September, and money is a big issue. They are playing a very big game for big gains. And we are all footing a tiny portion of the bill when we purchase their shares or are holding the shareholder "seat" of whoever did initially purchase them. Intellectually we all know that of course but at least we can see how HVSF's expectations compare to the average biotech. It's no guarantee of anything but it's food for thought... M. Alexander