fda ind

I know we are all waiting for some news about the submission of our IND and the start of the TT-034 trial but, in the meantime, I thought that I would post this excellent overview of the IND process.

https://ccrod.cancer.gov/confluence/download/attachments/78385937/Overview%20of%20the%20IND%20Process%20CBER%20101%20%E2%80%93%20An%20Introduction%20to%20CBER.pdf?version=1&modificationDate=1332447056173&api=v2

A couple of points that I found interesting are: it is possible to go from Pl to Plll and skip Pll if there is enough data to support that move, and the 30 days is not affected by the need to clarify points which the FDA does believe should halt the process.

So, if we got great results and we got a big pharma to give us some money, in theory we could apply to go straight to a Plll trial. Also, the FDA asking questions does not necessarily mean a hold on the process. A formal hold is first notified by telephone and followed up by a letter. The hold stays in place until the FDA is satisfied its questions have been answered and they get a new 30 day period to assess a revised submission.

If our application is as well constructed as we have been led to believe, then any questions raised should not be of the type which would cause the FDA to place a hold on the application. This means that if there are some concerns formally voiced by the FDA, we should be able to work through them while the recruitment process is taking place.