Biotech Values

[DewDiligence]

INO -19%/PM on delayed to VGX-3100 phase-3 program:

http://finance.yahoo.com/news/inovio-announces-fda-request-additional-120000050.html

Inovio Pharmaceuticals, Inc. (INO) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its proposed phase III clinical program for VGX-3100... This study has not yet been initiated and has not enrolled or dosed subjects. Additionally, the hold does not pertain to any of Inovio’s other ongoing clinical studies.

Inovio anticipates receiving a formal letter with complete information from the FDA within 30 days. In its initial communication, the FDA has requested additional data to support the shelf-life of the newly designed and manufactured disposable parts of the CELLECTRA 5PSP immunotherapy delivery device… Inovio estimates that the start of the phase III clinical program will be delayed until the first half of 2017 pending resolution of the FDA’s requests.