Various drug approval classifications by the FDA

[sargasso]

I find the below FDA drug approval classifications a bit confusing. Here is a summary provided by the agency. So in the best of all worlds which classification should we prefer for Imet? Where, exactly, does Imet fit into this scheme?

•Priority Review
•Breakthrough Therapy
•Accelerated Approval
•Fast Track

https://www.fda.gov/forpatients/approva ... 041766.htm

[sargasso]

My problem, by the way, from a layman’s point of view is these various FDA drug approval classifications tend to blend in to one another. In other words, they do not appear distinct. Perhaps it’s time for the FDA to eliminate these classifications altogether and start over; the goal being considerably quicker drug approval than presently exists (even with these various classifications) for serious unmet needs.

[Fishermangents]

Hi Sargasso, thanks for bringing this up and providing the link. I went through all 4 programs. They are overlapping in the sense that all 4 procedures require some significant improvement on current practice. It also seems that all 4 procedures are only applicable if it concerns a serious disease with unmet needs.

Comparing them in relation to imetelstat, I think that Accelerated Approval for R/R MF seems to the most likely, if one of these procedures should be applied. I think mainly because of the surrogate end-points and the new MoA of imetelstat. The new MoA would need a very long time to see long term effects. Because high risk MF patients don't have the time to wait so long this program may help. In addition, the only available curative alternative for high risk MF patients is SCT, which is a very invasive, high risk procedure, where only 10% of the MF patients can make use of. On the other hand, the latter could also indicate for Breakthrough Therapy.

Because of these small differences I am very happy that we have JnJ to lead imetelstat through this process. It will be JnJ who needs to apply for one of these accelerated programs in the first place. I am confident they will chose the right one.

I am not an expert in this, so other opinions are welcome.

[sargasso]

Fisher,

Thanks for your response.

To answer my original question (which classification do we wish?) from the point of view of investors and of patients we wish the classification that will lead to approval in the shortest amount of time. That much, at least, appears obvious (I think.)

On a positive note the fact that we are seriously considering these various FDA classifications shows how far we have come.