Tag archive for ‘Transcept Pharmaceuticals’
Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review (TSPT, $6.63)
Resubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are: Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to […]
Transcept Investment Thesis
Transcept just released a press release on July 12, 2011 with disappointing news on Intermezzo. The release reads as follows: “Transcept Pharmaceuticals(TSPT) announced today that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) on […]
Intermezzo is Likely to be Approved on its July 14, 2011 PDUFA Date; Then What (TSPT, $7.98)
Investment Thesis Transcept’s new drug for insomnia, Intermezzo, received a Complete Response Letter on October 26, 2009 in which the FDA acknowledged that it was effective. However, the agency failed to approve the drug because of concerns about dosing and potential next day residual effects. Transcept addressed and in my opinion has successfully answered these […]
Transcept Releases Results of Highway Driving Study for Intermezzo and Plans to Re-Submit NDA in the First Quarter of 2011 (TSPT, $6.61)
Transcept believes that the results of the highway driving study of Intermezzo reasonably answer the concerns of the FDA that caused the agency to issue a Complete Response Letter to the NDA in October of 2009. There is reasonable hope that the FDA will agree with Transcept that the study does answer their concerns […]