is this why fda delays are getting longer?, page-23

I know this is repetitive, but what possessed Alchemia management to go with Reddys, when any layman could see the problems. Poor decision making, as I said right at the time, probably should not repeat again, just that it was so obvious, and such a likely stupid move. It does show how illogical medical leaders and managers can be, they have never been known for their common sense. For instance, they are applying for FDA approval (which is in the USA) so they go for an Indian company, dumb, dumb, dumb..., super dumb. So who do you go with? You do the research, run the numbers, stack up the figures of all American companies and their success rates, and times, with the FDA over the past couple of years and go with one. Simple, logical, expeditious, in fact, far too simple for medical company managers.

The management of ACL should be held accountable for this.

As it stands, my gut feeling is that the FDA and Reddys have done a deal with Glaxo for a delay, similar to the one that was investigated between the FDA and Glaxo in 2008 (so it should not surprise anyone, it is not as if this is the first time), so now I am expecting further excuses in order to promote further delays, my guess is FDA approval around October 2011 now, that gives Glaxo, the FDA, and Reddys time to make a lot more money.

The problem is that there is just no financial incentive (or any other incentive) for them to grant approval to ACL, it is all to do with finance and profit and nothing to do with integrity or justice or science. You have to remember that we are dealing with human society here, American profit based society. I think that is the realism at the heart of the issue.

So, it is quite clear how FDA officials are making money out of the delays, and that is via Glaxo, there are probably a few driving around in new Mercs or BMWs, and they probably had some nice holidays this year, all subsidised of course. Glaxo make millions of dollars by the delay of course. But what about Reddys, how do they profit from the delays. Well, recently, Reddys signed an agreement with Glaxo to represent certain Glaxo interests in the USA. Is anyone naive enough to think that the issue of ACL and Fonda did not come up in the Glaxo and Reddys talks.

Like I have said before, this whole approval process for Fonda smells fishier than my fishing bag (and after a week down south catching bream, my fishing bag stinks to high heaven).

Gw