To: jbershad who wrote (1015 ) 1/1/1998 11:12:00 PM From: D.Right Read Replies (1) | Respond to of 2173
Happy New Year, everyone. Let's see what AMLN will have in 1998. They will finish the enrollment for the two European clinical IIIs in the first quarter. The duration is half year, so the results should come out in the fourth quarter. They will also finish the enrollment for the two US trial IIIs in the second quarter. The duration is one year, so the results should come out 15 months after the enrollment. This is the one to watch as it will decide the delay they announced in last Nov. is for 12 months or 18 months. If it can be done in early second quarter, it is close to a 12 months delay. If it is done by late second quarter, then at least 15 month delay. Sure, it is the results that count. But, enrollment is just as important. Once enrollment is done, the rest of it is automatic, it is the point of no return. So, watch out for the on schedule completion. About the insulin control in these trials, I had a chance to read a report on AMLN by H&Q dated from last Aug. It said patients will be monitored for three months before get enrolled, while they were only monitored for one week for the last two trials. I think it makes sense. Becuse the last trial for type II is positive at half year, the European tial should be postive for both type I and II. Of course, the question is the number will be how much better than .38% to .39%. I am counting on slightly above .5%. If that happens, AMLN will have a easy time to do one more round of financing and heading into the final stage of pramlintide development. Also, as we have all the bad news out now, who knows, we may even have couple of pleasant surprises. For example, if results are really good coming fourth quarter, JNJ may exercise its options as $12, then AMLN doesn't have to do financing anymore. If the numbers are great for type I, there is still a outside chance they can file the NDA for type I by the end of the year without waitting for the US results. The potential is there, all we need is some good luck. Have a great 1998. D.Right