I've corresponded with DI on a few occasions and I cannot remember him ever giving concrete dates for any specific event. I believe he's honest about what he's saying, and while he may make it sound like it won't be that long, soon can be interpreted very differently by different people.
Year's ago Mitch Sayare was the CEO of IMGN, when he said something would happen soon, you could be certain it would happen, but sometimes soon meant in a year or so. It got to the point where posters spelled it backwards when Mitch used soon, it became NOOS in our posts.
In investing in biotech's, I've learned nothing happens quickly. It's been said that Congress would take 6 months to determine how to make 3 minute eggs, but the FDA isn't as fast as Congress. I believe the SAP is what's resulted in delays, I wish I was sure it's now behind us. I believe the problem is you cannot simply sit down with the regulators and pound out an agreement. You submit, they comment, you submit again. Each time you submit they take another 30, 60, 90, whatever days before they comment. The same thing occurs on BLA or NDA submissions, they get 6 months, or 1 year to act, and if their action is to ask for something, once you provide it they get another 6 months or a year to consider your reply. In most every case cancer drugs gain the 6 months priority, but regardless, why not have sit downs with the FDA and make decisions then and there. When trial results clearly justify approval, why not reach that agreement immediately and move into a Phase 4 where all results need to be reported to verify how good the product is.
Gary
