Ryan, how convenient of you to leave out the critical word EXTENSION, as in OPEN LABEL EXTENSION study. Now I have to say you seem aware enough and bright enough to know the difference. This is a study offered to people who have participated jn the earlier randomized, double blinded, placebo controlled studies after they were unblinded. So I have to assume you are deliberately misleading the board when you make such obfuscatory statements. Mores the pity because character is everything. So when you accuse me of dishonesty, I believe it is your own dishonesty putting out a smokescreen. Lopitamide was titrated and Mipo was not. Mipo is actually the more potent LDL reducing agent. People of this board, be aware in phase two studies at 400 mg dosing Mipomersen reduced APO B100, the building block of LDL cholesterol, to undetectable levels. So arm yourself with facts and do not allow yourself to be manipulated. If after evaluating the facts, you like AEGR, then I sincerely hope you do well. As I said before, I seriously doubt the supposed facts some present around here starting with Mr. Beer on down.
Why did Dr. K one of the top lipidologists note that the data between the two products was noncongruent in Mipo's favor? Also, if you want to pay attention to detail why aren't you worried about the HDL lowering with MTP inhibitor, even five to ten percent could be vital? How about fatty acid accumulation in the small intestine? How about worry about an incomplete letter from the FDA with AEGR' s bank account? I personally don't short stocks but the great white sharks are stocking this one. I'd get some shark repellent( puts) if I were you. t
endspeed: not sure I follow your email, can you please explain why a "randomized, placebo controlled, double blind study” would represent a superior trial" - given that there are no standard of care (i.e. no placebo ) ? I am fairly certain that the FDA would object to such a trial design out of ethical concerns. Your suggestion seems to indicate a lack of understanding on trial design and a lack of honesty since Isis HoFH phase III trial is designed the exact same way (i.e. single group open label). Don’t take my word for it - look it up on the FDA site:
Verdict will be out soon – NDA for both Isis and AEGR should be filed by end of year with regulatory pronouncement in 2012.
Also, do you really need me to explain how one estimates efficacy on a single group open label trial ? You seem to suggest that you have studied this closely - I assume you can do a little more work in this area and satisy your curiosity...
You're right on Endspeed but if you're a loyal AEGR follower you don't want to hear that. Even SGEN that got a 10 to 1 vote for approval from the FDA committee doesn't make either SGEN or the market feel secure about approval for their latest drug. With 23 patients left in this single armed chensy study I just don't feel how Mr. Beer, that's Mr. with a capital M, can feel secure like Mr. Beer translates to the devoted brethren followers. I guess we'll see, but some of the shorts are already trying to take the little kahuna down with their am bids of like $6.5 per share. It will be interesting to see what happens with this stock from Disneyland. t
I am not being dishonest. AEGR to my knowledge has not done a randomized, placebo controlled, double blind study at a fixed dosage for Lopitamide so how may I compare the efficacy? Your reasoning may work with those who haven't studied this closely but it does not even merit serious consideration. If you believe what you are trying to sell I hope you don't have your children's college funds invested in this area. Don't state the obvious and tell me these people must watch their diets. You are not exactly delivering a news flash. Lopitamide has debilitating side effects that intensify when patients are unable to maintain a very Spartan lifestyle. That is the point here. With debilitating side effects come patient noncompliance and subsequent discontinuance of taking their med altogether. I will state it again. Mipomersen given to patients using Lopitamide's protocols would lower patient LDL measurements more effectively. Lopitamide's trial allowed dose titration and Mipo's trial did not! What is so hard to understand about that?
But still no argument of substance in regards to the compay's claim. And your denying that you are not Mr. Beer does not make it necessarily true. I can envision you looking over your left shoulder for some help from the scientific officer for an answer like the old days before he resigned and no one is there. Kind of like " master- blaster" in the old Mel Gibson movies. Good luck without blaster Mr. Beer. T
BTW ches buddy I'm not bragging about anything, just pointing out truths. Do you dispute what Dr. K said? If so good luck when the short- reapers come after you for six bucks a share. If you are Mr. Beer you can only hold the stock up so long with your artificial pumping, Enron people learned that. T
You can insult people but can not argue anything because you have no knowledge. Hey that's OK if you are a little bit challenged. Hope before X-mas you can learn the difference between DNA and RNA. Also, I really hope whatever shorts that are out there don't bankrupt you with their attempted bids for the for stock at six bucks. No substance and they'll be coming for you. The CEO may pump it up a little bit longer so look for your chance to bail. T