I did some DD on the EU approval timeline. It goes something like this - it's 210 days from start to finish HOWEVER there is a "stop clock" built in during which the EU sends their findings to the company to ask for more information. This can last up to 3 months and can be extended to 6 months if needed. After the company responds the clock starts again and runs to day 210.
Of note:
- The 210 day timeline is by law the max. A decision can occur sooner.
- A decision is binding to EU member states.
- There can be a second "stop clock" during the second half if more outstanding issues are identified.
- The process is transparent. There will be monthly reports and press releases.
- There is an accelerated process in which a decision is made in 150 days instead of 210.
So best case scenario - Advaxis submits on Day 1 of Q4 or 10/1/2017. They are granted accelerated approval process and take 1 month in the stop clock phase and all goes well, thats a total of 180 days which puts approval at approximately 4/1/2018.
This is an approximation, remember, approval COULD take less time than even the 150 days they give themselves.
Worst case (ending in approval) - Advaxis submits on 12/31/2017, doesn't get the accelerated process, and takes the full 6 months in the stop clock phase and another 30 days in the second stop clock phase for a total of 420 days. That puts us in late February, 2019.
The mid-point of these two dates is sometime in September, 2018. Or about a month before the warrants expire.
I find it exciting to see that the process is transparent. We'll have to keep an eye on this after submission and look for clues as to the progress.
