AI
Friday, July 27, 2012 1:29:41 AM
TLON..$1.71 & ONXX..$77.72..Audio Chart & DD Review on 7/26/12. My thoughts on upcoming PDUFA for TLON on Aug 12th as well as approval of Kyprolis (Carfilzomib). Both were/are under review by the FDA for Accelerated Approval. http://chart.ly/2xuxdww
Original DD Post on June 28th at $1.00 http://bit.ly/LVQ0O9
Message in reply to:
TLON..$1.64 The ONXX approval of Carfolzomib was huge IMO. Their approval was one week early. Those were the only two drugs (Carfolzomib & Marqibo) all year with Accelerated Approval (standard review) in 2012. Carfilzomib was approved on July 20th. A few others had priority review. Both had positive ADCOM Mtngs. The company is in label negotiations with the FDA. An analyst, gregory Wade, with Wedbush Securities thinks that is a very positive thing. http://bloom.bg/IDzv8m
This stock seems to be getting moved by big money like Warburg Pincus. They have 3 seats on the board of directors of Talon. What is big money? http://bit.ly/xkOh0d
http://www.warburgpincus.com/portfolio/ViewCompany,id,480.aspx
http://www.warburgpincus.com/portfolio/Default.aspx
The Phase 3 study now under SPA, named HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo. Talon expects to know if the NDA has been accepted for filing by the FDA in mid-September 2011.
A Caveat from Dr. Pazdur In 2005 he (Richard Pazdur) stated: “If there is no available therapy, then a single-arm study with a good response rate might be acceptable. he explained. After accelerated approval, a sponsor must prove clinical benefit by a separate confirmatory trial. The agency would like this trial to be underway before granting accelerated approval.
Original DD Post on June 28th at $1.00 http://bit.ly/LVQ0O9
Message in reply to:
TLON..$1.64 The ONXX approval of Carfolzomib was huge IMO. Their approval was one week early. Those were the only two drugs (Carfolzomib & Marqibo) all year with Accelerated Approval (standard review) in 2012. Carfilzomib was approved on July 20th. A few others had priority review. Both had positive ADCOM Mtngs. The company is in label negotiations with the FDA. An analyst, gregory Wade, with Wedbush Securities thinks that is a very positive thing. http://bloom.bg/IDzv8m
This stock seems to be getting moved by big money like Warburg Pincus. They have 3 seats on the board of directors of Talon. What is big money? http://bit.ly/xkOh0d
http://www.warburgpincus.com/portfolio/ViewCompany,id,480.aspx
http://www.warburgpincus.com/portfolio/Default.aspx
The Phase 3 study now under SPA, named HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo. Talon expects to know if the NDA has been accepted for filing by the FDA in mid-September 2011.
A Caveat from Dr. Pazdur In 2005 he (Richard Pazdur) stated: “If there is no available therapy, then a single-arm study with a good response rate might be acceptable. he explained. After accelerated approval, a sponsor must prove clinical benefit by a separate confirmatory trial. The agency would like this trial to be underway before granting accelerated approval.
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