By Andrew McDonald:AP Pharma (APPA.PK) intends to resubmit the New Drug Application (NDA) for APF530 in 1H12 after working quietly and diligently on addressing all the issues raised in a March 2010 complete response letter (CRL), which the FDA issued in response to the original NDA filing (May 2009).
By Markus Aarnio:Arena Pharmaceuticals (ARNA) is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs-- an important class of validated drug targets-- in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
By Brian L. Wilson:The up-and-coming drug company Vivus (VVUS) is about to get its complete response letter to the NDA that was submitted, which could finally give us an FDA approval for Qnexa. If you remember, this NDA was delayed back on April 17th for three months.
FDA reviewers have recommended that the FDA issue a complete response letter for the NDA for rivaroxaban (Xarelto, Johnson & Johnson). This story will be updated later today with with more details, but here?s the bottom line from the FDA?s review: Based on our review of the clinical data, we recommend a complete response. Reasons ...
By Larry SmithTranscept (TSPT) 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. It plans to re-submit the NDA in the first quarter of 2011.Complete Story »
Smith On Stocks submits:
Transcept’s (TSPT) 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.
Mike Havrilla submits:Below is a summary of generic/specialty pharmaceutical company Lannett’s (AMEX:LCI) current financials and expected upcoming FDA catalysts. I received the following email feedback from the CFO, Mr. Keith Ruck, in mid-April regarding the status of the pending FDA decisions after recently announced conclusion of the FDA pre-approval inspections.Mr.
Steven Breazzano submits:Long investors in Protalix BioTherapeutics (AMEX: PLX) awoke Friday morning to a press release announcing a CRL (Complete Response Letter) from the FDA. While the stock immediately sold off to the mid 6’s before recovering to mid 7’s (a 19% dis