yoyo, page-12

FDA labelling is critical because it limits the legality of claims that can be made for marketing/advertising purposes - you naturally want to stretch claims/indications to the limit - based on all the scientific evidence.

CDC of course set the practical formal guidelines for clinical use and most institutions and individual state authorities will rarely fund usage until CDC guidelines are inplace.

Individual medicos can use products for "off label" purposes if they believe it is justified. However, companies are not allowed to promote off-label uses

However, I don't think labelling is an issue with "in-tube" because of what has gone before with the oringinal QFT approval and supplementary approvals.

The delay has been clearly stated to be associated with the shelf-life of components of the "in-tube package". It surely cant be long now given the amount of data CST already would have. It does take some time to put together these data into regulatory style format and "approval clocks" stop and start in very formal ways.

Generally though the FDA will be fairly reasonable in these circumstances and grant approval with the Sponsor Company making commitments to perform an agreed range of ongoing stability studies at various parameters.

Approval must be very close - I honestly can't see any major issues from here.