FROM A YAHOO POST -GOOD ANALYSIS OF TRIALS AND RES
Post# of 95
FROM A YAHOO POST -GOOD ANALYSIS OF TRIALS AND RESULTS TO COME
THLD's stock remains flat because of focus on Abraxane and the " race " to market for the pancreatic indication.
Mid 2013 will be the major catalyst for THLD stock in my opinion and here is why. Enrollment in the phase 3 sarcoma trial is probably ahead of schedule due to investigator interest, much like the enrollment for the phase 2 pancreatic trial. The Sarcoma trial has a orphan designation as well as an SPA with the FDA. That means the agreement for the trial design and outcome are agreed upon between the FDA and THLD. Interim analysis of the phase 3 sarcoma is projected to arrive at about mid 2013. At that time, if the analysis proves to be a repeat of the stellar outcome of the phase 2 sarcoma trial with safety intact, THLD would probably be compelled to go for the NDA with the FDA's blessing. Approval of the already agreed upon trial parameters and goals would probably be guaranteed . Celgene does not have an SPA with the FDA for their phase 3 pancreatic . THLD has an agreement.
We might be talking apples and oranges when it comes to pancreatic trial vs sarcoma, but the bottom line is THLD has SPA with both indications and CELGENE does not.