Phase Biotech, which provides clinical trial update information for doctors and not investors covered Alnylam. I think alot of those doctors will become investors though. But how long will it take for RNAi therapy to get approved?
zd . . . for Alnylam . . . AT LEAST ANOTHER DECADE!
Look . . . it took ISIS more than 16 YEARS to figure out SAFE, EFFECTIVE drug DELIVERY for SINGLE-STRANDED RNA - - with 2nd & 3rd Generation Antisense Technology. . . and you may know one of Potted's most FAMOUS mantras . . . with RNAi . . . "Double-Stranded is DOUBLE TROUBLE!" . . . http://www1.investorvillage.com/smbd.asp?mb=569&mn=12354&pt=msg&mid=4436615
Alnylam not only has to COPE with UNCONTROLLED and VARIABLE "TLR" effects with RNAi (Toll-like receptor effects . . . spoken by Dr. Ambati - - which now HAUNTS the Halls of Alnylam! . . . like a GHOST!) . . . since the human body views double-stranded RNAi as a VIRUS! . . . but the whole process of RNAi . . . it sometime makes INCOMPLETE COPIES ( like an over-worked Xerox machine! ) . . . and this leads to DOWNSTREAM OFF-TARGET GENE REGULATION! . . . ( a very BAD thing!!! ) . . . and a topic RARELY discusses by the Alnylam Dream Team! . . . and this is STILL a big, BIG problem YET to be RESOLVED . . . IF EVER!
So Potted's BEST projection for SAFE and EFFECTIVE RNAi drug delivery . . . . is AT LEAST a decade from now . . . if it is ever accomplished. . . Let's face it . . . at the rate Alnylam is going now . . . and the PROBLEMS that keep RE-SURFACING! . . . with initial CLAIMS of SUCCESS! . . . and then the clinical trial TERMINATED! ( Shhh! . . . keep this quiet! . . that was Tekmira's latest SNALP trial FAILURE - - Alnylam's drug DELIVERY partner! ) . . It's like the "Dream Team" has their definitions of "SUCCESS" and "FAILURE" SWITCHED! . . . and then another Alnylam drug candidate "PARKED" . . . and another trial "Starting-Over" . . . just WHERE are the TANGIBLE SIGNS of PROGRESS? . . . Honestly . . . Just where are they???
And zd . . . all we get from JM is more FALSE PROMISES! . . . ( e.g. two BIG partnership deals in 2009! ) . . . As you may know . . . Potted called for JM's dismissal many moons ago . . . he was RIGHT for Alnylam in the early developmental days . . . to generate early EXCITEMENT in the field with "dreamy promises" of the RNAi technology! . . . and NO ONE could do it better than JM! . . . but when it comes to hard, HARD therapeutic drug development . . . and the expected failures in human CLINICAL Trials . . . and developing a SUCCESSFUL STRATEGY for all of that . . . and a COMMUNICATION strategy for the shareholders . . . well . . . JM just comes up SHORT! . . . that's NOT his strong suit!
So for Alnylam . . . Potted not ONLY questions the success prospects for RNAi . . . but Potted also QUESTIONS the top management now at Alnylam! . . . and that's why Potted thinks the ALNY stock price has FURTHER to DROP! . . . and that's why Potted says . . .
Go to the Head-of-the-Class with ISIS!
<< But how long will it take for RNAi therapy to get approved? >>
In Potted's view . . . at LEAST a DECADE! . . . Just READ what Alan Sachs, Vice President, RNA Therapeutics, Merck Research Laboratories had to say about RNAi . . . "Merck’s Alan Sachs, on RNAi’s Big Challenge: Delivery, Delivery, Delivery" . . . http://www.xconomy.com/national/2010/01/21/mercks-alan-sachs-on-rnais-big-challenge-delivery-delivery-delivery/
Here's the "take away" . . .
1) According to Alan . . . Liposomal delivery for RNAi is very PROBLEMATIC! . . . SAFETY is the BIGGEST CONCERN! . . . and LOOK . . . . we just saw Tekmira's ApoB SNALPs FAIL! . . . and Alnylam is now SCRUBBING any PR documents for the words "Tekmira" . . . and "SNALPs!"
2) Merck now sees the greatest potential for RNAi as a "lab technique" . . . for drug target VALIDATION! . . . to "de-risk" small-molecule drug development! . . . Actual "workable" RNAi drug therapeutics are many, MANY YEARS away!
3) The REQUIRED IV drug administration for RNAi-based drugs LIMITS the overall market potential for RNAi! . . . RNAi for Cancer . . . Possibly yes! . . . but RNAi for chronic diseases . . . such as Cardiovascular diseases . . . Metabolic diseases ( Diabetes, etc. ) . . . and other chronic diseases . . . LIKELY NO! . . . the IV drug delivery is NOT APPROPRIATE!
4) The "deflation" in the RNAi "gas-bag!" will continue over the next few years! . . . JM's proposed 2009 "deals" VAPORIZED because the bio-market NOW KNOWS that the "State of RNAi in 2010" is still VERY IMMATURE!
Go to the Head-of-the-Class with ISIS!