referral to ema, page-54

Resourced,

I couldn’t work out from the fin numbers the cost of production of that trial run and so from a financial point of view to try to decide whether it was excessive or not, but if that was the size of the run they had to do to prove up their manufacturing process then that is what they had to do. Fortunately the product appears to have quite a long life span so much so they can just stick the use by date on it after the CE mark has been given – whenever that may be. From my exposure to biotechs over the years the good ones run at about 75 to 80% gross profit margin that’s why when you get one that works they turn out to be very rewarding. Such high margins generally mean that the costs of running the show including the production costs are relatively low, so perhaps the cost of production of this large run may not have been all that high so it may not be of much consequence.

In respect of this CE referral I suggest if it is a sole BSI issue then it will be resolved quite quickly – they couldn’t afford a stuff up and will no doubt call in a few favours. If it is a sole TIS issue then I wouldn’t expect this to be resolved within months as goodness knows what extra measurements and tests will be required.

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