EU approval aheadI may have been wrong with my earlier estimate that the submission of Isolexx for the EU wide marketing authorisation may stuck at the EFSA and may need another 6-12 months (which BXI may not have anymore without such an approval; without EU approval = no committment from a European partner). Even CS may be wrong and maybe first ever there will be a positive suprise with regards to a BXI time schedule!
Some of you may have observed the EFSA webpage, where it registers all submissions and where it indicates deadlines for finalisation of the EFSA assessments:
(https://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panel=ALL > then filter food sector area for
"Novel Foods", click search).
| M-2013-0069 |
EFSA-Q-2013-00231 |
Request to the European Food Safety Authority to review the opinion on the safety of "Rapeseed protein" as a novel food ingredient (Bioresco on behalf of Helm AG)
|
Nutrition
|
NDA |
|
|
27/06/2013
|
Several weeks ago, one or two have mentioned here, the status was changed from
"in progress" to "
additional data request" and the orginal deadline of 12 July was changed to "
clock stopped".
You can see now that there was an update (27/06/2013) of the status and now is again back to "in progress". And when you click on EFSA-Q-2013-00231 (via EFSA HP - not from here directly), you can also see that the deadline has been changed back from "clock stop" to 12/07/2013 !
Yesterday afternoon I talked with one of regulatory affairs colleagues who deals in our company with EFSA applications in the area of food additives. According to his experience, there is only one interpretation: Bioexx (Helm AG in Europe as its partner) has submitted the reqested additional data to EFSA and apparently the EFSA has been satisfied with these data - otherwise EFSA would have extended the deadline!
My colleague recommended to watch the activity of the expert panel who is dealing with this application, which is the Nutrition Panel. According to him, if the EFSA wants to finalise this application by 12 July, there must be very soon the publication of the agenda for the next meeting of this panel which takes place on 10-
12 July. See here:
https://www.efsa.europa.eu/en/nda/ndameetings.htm
(where also the agendas of previous meetings have been published).
According to my colleague, without knowing much about canola protein, he would anticipate a positive outcome if EFSA finalises an assessment by the date of the originally indicated deadline - otherwise, if EFSA is not satisfied it rather requests again for additional data and the deadline is extended, extended.....
So watch this site here: https://www.efsa.europa.eu/en/nda/ndameetings.htm
If the agenda for the July 10-12 meeting indicates canola/rapeseed from Helm Ag, then we most likely get the EU approval pretty soon.
IMO this is very essential for any deal with an European partner would also trigger significant interests and committments from European enterprises if the EFSA issues a positive opinion on Isolexx.
The volumen is very low presently, but I have saved my money by selling at 0.65 and have no problem to buy now progressively until. Some now, some maybe in July. If above is correct we should a recovery of the sp over July !