What are you expecting to happen at 90 days? The evaluation period target for the MAA with expedited review is 150 days, 90 days might be the earliest any action could be expected, but it's certainly no guarantee. Remember their filing was 1.7 million pages, certainly not every one will be scrutinized, but I believe the company is asking for more than approval in GBM, or even all brain cancers, time will tell how much they get.
While all longs would love to see an early approval, it's foolish to count on it. 150 days puts us well into the second quarter, I'm fine with that. In roughly two weeks we should see the Annual Report, it's hard to say how much will be said there that isn't said in a quarterly, but they certainly have a vehicle that they could say more in. It's up to management as to how much they say, how much they wait for the Annual Meeting or action by the UK, the ball is in their court. We were given a heads up on the EDEN, but it was far from telling us when it should be available for commercial production of DCVax-L.
I would hope that any new trial utilizing DCVax-L clearly indicates it's made in the EDEN unit. I don't believe new trials will be initiated until we have at least UK approval, but anything is possible. From the time an IND is first filed and a trial begins is often many months, in some cases it can take a year or more. In IMGN's case, much time was taken because they wanted a specific Dr. as their lead clinician and a great deal of time was taken by him and the IRB to be available to start the new trial. If the next new trial initiated for DCVax-L isn't in GBM, I would suspect that someone with no current knowledge of DCVax-L, but with expertise in many solid cancers, would be selected to be lead clinician. That person might be from UCLA where Dr. Liau could assist, but I don't believe she'd act as the lead clinician of any such trial.
It seems to me that when we're discussing days, how many days are we into peer review by Nature into the article they're peer reviewing. I really don't know, but if we've learned anything it ought to be that such reviews take a lot of time, perhaps more time than the regulators allow themselves to judge a filing for approval. Nature's manuscript was submitted well before the MAA, what's the likelihood that we'll get approval before publication.
Gary
