On what basis is Mr. Ward the stock analyst basing his statement that FDA is treating line extensions as lower priority. Last I knew FDA had to meet PDUFA timelines with line extensions as well as with NMEs. The veracity of this statement could have been easily checked by the reporter.

What about Mr. Viehbacher’s statement. Last I checked the FD&CA has standards for approval of a modified release product. Either it met it or it didn’t, if it met it the FDA has no choice but to approve the product. Mr. Viehbacher is essentially safe to claim anything he wants to and FDA can’t respond.

Why did Glaxo simply withdraw the application and not appeal the decision within the FDA? This is extremely strange. The reporter could have and should have asked Glaxo to provide copies of any communications with the FDA. Typically when a sponsor withdraws the application the FDa writes and acknowledgement letter that may include the reasons. Also there must be other communications. Why didn’t the reporter ask Glaxo for copies of any communications. Better yet why not ask Glaxo to waive confidentiality and let the FDA release copies of any reviews, etc..

Typically when big companies work on a line extension they put their D team to work on it. Seems to me that Glaxo management may not have provided sufficient oversight regarding the project and was unaware of major problems with their program that jeopordized their franchise.

If I were a big investor in Glaxo stock I’d sure be interested if Glaxo management made my investment go south because of poor management.

Looks to me like this article is more about Glaxo executives trying to divert blame from themselves.