Replies to post #198082 on Elite Pharmaceuticals Inc (ELTP)

[lasers]

As for the FDA, by designating "Priority Review" for $ELTP SequestOx, they have moved forward the PDUFA date to Jul 14, 2016. In comparison to other NDA and BLAs that I follow this apparently is a 5 to 6 months advancement for SequestOx.

For example Vericel MACI™ BLA which submitted on the same time period as SequestOx has a PDUFA of Jan 3, 2017, which is a six month longer wait. Vericel's FDA acceptance was on March 07, 2016, and $ELTP was on March 17, 2016.

[Jimmy Joe]

As for the FDA, by designating "Priority Review" for SequestOx, they have moved forward the PDUFA date to Jul 14, 2016. In comparison to other NDA and BLAs that I follow this apparently is a 5 to 6 months advancement for SequestOx.

For example Vericel MACI™ BLA which submitted on the same time period as SequestOx has a PDUFA of Jan 3, 2017, which is a six month longer wait. Vericel's FDA acceptance was on March 07, 2016, and $ELTP was on March 17, 2016.

That is what I and several other posters have been trying to say throughout. Priority review takes 6 months minimum and often up to a year or longer for some drugs.
This has got to be on the FDAs HOT things to do list. Timelines for ELI-200 priority review have been pushed up IMO.

90% or > chance the priority review is approved.. also my opinion.

Thoughts?

BTW thanks for your Canada take. Cannot imagine any country putting money first over people. The abuse problem itself has got to be costing Canada bookoo bucks right now. Not to mention as the article pointed out the problem is growing in Canada and so has to be the cost in terms of treatment and other factors that go into this epidemic.

Hope they are waiting for Elites solution.