The badnews is no approval soonAs much as I hate to say it, the bad news seems to be that E.coli vaccine approval is not around the corner. Although some on this board had predicted approval was imminent, the following statement does not seem to bode well for this issue:
"U.S. submission is expected to be filed in the late second quarter or early third quarter of fiscal 2006. We are still awaiting direction from the CFIA regarding their requirement for a study to prove the safety of the vaccine in the event of accidental injection into the administrator. Thus, the timing of the Canadian submission is not yet known."
With BNC's history of missing milestones, I hate to guess how long this is going to take. My guess is that commercialization of the vaccine could be 2007 or later (not sure how long the regulatory agencies will require to review it before giving permission to commercialize). But I hope I am wrong (come on BNC: prove me to be wrong, pleeeaassse!!).
I think we should also all be aware that submission does not mean approval. Many products to get rejected for either safety or efficacy reasons and we have really only been hearing BNC's side of things. Other products require additional studies (for an example of this, see Inex Pharmaceuticals which has been essentially wiped off the planet because the FDA requested one more additional study even though its Marqibo drug seems to work).
I am still long on BNC. I just want to be realistic and wish things could move along a bit faster. At this point, I am not sure if BNC could be doing anything different. However, from my perspective, they should not have been telling investors that approval was imminent for all these years (I remember seeing the CEO on ROBTV 3-4 years ago and he was predicting approval was around the corner.)