Well, I'm not entirely familiar with the details, but here's what Fast Track means to me...
NOTE: There was a small PII (if memory serves) in Europe that I assume was the basis for this designation. I believe it was under 15 patients. The data must have been pretty good for Fast Track. Also, epratuzumab has already been through several trials for other indications that demonstrated safety.
So, what this means in this case....
> It's possible to do a "rolling submission". That is, the potential exists for starting treatment before PIII is complete, assuming that efficacy and safety are shown. This is very important to IMMU since it means they don't have to get as much new financing over the next year or two.
> Any partnership (which IMMU has publicly stated they are pursuing one) has to be easier with this designation. I'm sure they can strike a better deal with a partner with Fast Track in hand.
> It's really the first time in the company's history that they've been in this close a relationship with the FDA.
> The investing public has some evidence that the chances of FDA approval are much higher than they were before since some efficacy must have already been demonstrated. Further, I don't believe the FDA often grants this designation if there are other drugs already on the market for the indication. So, I have to assume that either this is either very much better than anything else currently on the market or is really the first drug available for Lupus. Either way, there is the potential that this would be the first-line treatment for this, and that's a very nice thing to have.
All that said, there is still the potential for this to be worthless. More than one drug has gotten fast track only to be proven useless for the indication. I don't think that this is going to happen in this case, but you never know.
At any rate, for people who have hung around in this stock for years, this is the first time that I've seen this kind of news. All of the rest of the news was from the company and of the "things are going well" variety (apart from the AMGN deal, which was a disaster). Getting this designation is a very different thing, something that an objective observer (which I'm not <G>) can hang their hat on.
What would be icing on the cake would be for a partnership announcement to be made, one with, say, $50MM - $75MM up-front (or in relatively near milestones) and the partner taking over many of the costs of the PIII trial. Given the history with AMGN, however, I'm sure that Dr. G. and company are reluctant to cede all control over to any potential partner without strong guarantees.
Well, enough meandering. The short summary is that Fast Track gives IMMU much greater credibility when than it had before that designation. That's got to help when searching for ways to finance the PIII trial and/or partnering. That said, I don't really expect this to have a huge pop immediately. But I do expect it to cause "the street" to take another look at IMMU, especially if we get a partner on board.
Best
Erick |
