As things stand, we have a few data points that purport to...

As things stand, we have a few data points that purport to provide a guide - some would suggest a pinpoint guide - to the timing of generic fonda approval.

These data points include:

1) Observations made by Dr Reddy around their expected timeframe for commercial launch

2) The fact that FDA hasn't asked any questions since October

3) Bioshares preparedness to draw firm conclusions from the time lag between final plant inspection on 7 January and an expected approval date.

. . . .but what I don't know is whether there's a final stage. This might - for argument's sake - include all of the paperwork being brought together and passed to the "FDA Approvals Officer" who has a policy that he takes out the generic fonda file each day, flicks through it, and then picks up a 100 sided dice, which he rolls once. HIS rule is that he will only get out the approval stamp if he rolls a 67 that day.

Additional "facts" weighing on my mind include:

- There were very strong market rumours - effectively down to the day - regarding timing for Acrux FDA approval late last year. These proved to be correct. . . . but I don't quite know what that confidence level was based on.

- There are plenty of ANDA application numbers either side of the ACL application that are yet to receive approval. I've not done the stats, but it is certainly feasible that at current approval rates many of these won't be approved even in 12 months time. ARE ALL OF THESE APPLICANTS similarly confident that their approval should be imminent?

IN short, This post is a cry for help.

Is there any reason why we DESERVE To be confident that FDA approval is very very close. Or are we all just HOPING, and unable to find any reason why it should not be just around the corner??