CO, I wish it were so, however, I've been in companies that were turned down by the FDA before and they too must issue news on the negative news. In most cases new trials may be adequate to approve the product, but that's years and hundreds of millions in additional expenses. IMGN's Elahere was such a case, the initial trial demonstrated efficacy where IMGN expected it, but the FDA had broadened the target in designing the trial. When they ran a smaller trial where IMGN wanted it in the first place they gained approval, but had to confirm it with a larger trial, which was approved after the buyout.
A small delay would probably not require a PR, but if the company is notified of something that will require significant time to resolve, they will need to PR it. Certainly they'll put as positive a spin on anything that they can, but it will have to be announced. Many have reported that the 150 day decision period has a built in pause if more information is requested from the company, that's where potentially up to 60 days could be taken. One generally knowledgeable poster indicated that no RFI was submitted to the company, but I don't believe it's possible to say for certain that this is the case. The truth is, we'll never know about all the discussions the company has with the UK or any other regulator, I suspect that all companies communicate more than any of us believe they do.
Communication with a regulator isn't always fruitful. Genentech decades ago almost certainly spoke with FDA staff in designing a registrational Phase 2 Trial for Kadcyla. When they filed for approval based on the results, Dr. Padzur refused to look at the filing as he didn't like the format of the trial. I believe his staff got the message not to agree to new protocols without speaking with him about it, and Genentech spent a few more years on a Phase 3 which was underway, and would have been a confirming trial, to gain approval. Just another tale of the FDA holding up approval for years of a product which should be approved. I suspect that perhaps tens to hundreds of thousands of patients were prevented the benefits from Kadcyla because of FDA action, or lack of it.
If two weeks from now we don't have an approval, I believe we can assume that the company did receive a RFI and the delay will be whatever time has been required to deal with it. Meanwhile, if there was no RFI, we could gain approval on any day between now and then as the UK won't intentionally wait for day 150, they'll announce on making a decision. Of course we know, officially they post approvals twice monthly, but the company should be notified, and they have a few days to make their formal release. I'd rather see a few days delay, and get a release before the bell on Monday then if they immediately released on a Thursday or Friday as that's when they got the news.
Gary
