and further, page-33

I don't think that they need approval from the FDA to release results. However there are pretty serious consequences if there is any defect in the data which is found after release. It can, and likely will, result is significant statistical penalties and can result in otherwise good results being down graded to "failed to meet the primary end point". The data set on the smoking cessation trial will be a massive data set; about 130 patients with about ten factors tested for in sputum samples with at least eight visits per patient. Then there are daily sheets filled out by patients for about twenty observations. This is a massive amount of data and it has to be quality assured and any anomalies accounted for or corrected. This is a massive task for a relatively small team. Any error can be very damaging. Patience!