Dont think there will be an opinion today but all is looking good for items covered off. Looking back through agenda's and minutes for other companies most recently in the December agenda I saw the following for another business.
December Agenda
1. Oral explanations
(EMEA/H/C/002066), (ciclosporin), (treatment of keratitis)
List of Outstanding Issues adopted on 25.09.2014.
List of Questions adopted on 25.04.2014.
• List of experts to ad hoc expert group meetings held on 4 December 2014: Adopted by written procedure • Report from the ad hoc expert group meetings to held on 4 December 2014: For discussion Oral explanation to be held on Wednesday 17 December 2014 at 9.00.
Minutes from that meeting
(EMEA/H/C/002066), (ciclosporin), (treatment of keratitis) List of Outstanding Issues adopted on 25.09.2014. List of Questions adopted on 25.04.2014. The CHMP noted the report from the ad-hoc expert group. An Oral explanation was held on Wednesday 17 December 2014 at 9.00 focusing on the endpoints from the pivotal study with specific regard to the clinical effect on signs and symptoms. The members discussed the available clinical data and the relevance of the primary endpoints and secondary endpoints. (NO OPINION GIVEN YET)
January Agenda
2. Initial full applications
(EMEA/H/C/002066), (ciclosporin), (treatment of keratitis)
List of Outstanding Issues adopted on 25.09.2014.
An Oral explanation was held in December 2014.
List of Questions adopted on 25.04.2014
January Minutes (THIS IS WHAT WE ARE LOOKING FOR!!!!!)
2. Initial full applications
Ikervis (EMEA/H/C/002066), (ciclosporin), Applicant: Santen SAS, (treatment of severe keratitis in adult patients with dry eye disease) Known active substance (Article 8(3) of Directive No 2001/83/EC) An Oral explanation was held in December 2014. List of Outstanding Issues adopted on 25.09.2014. List of Questions adopted on 25.04.2014.
The members discussed the outcome of the clinical studies in terms of efficacy and the clinical relevance of the observed effect. The majority confirmed that all issues previously identified in this application had been addressed. The Committee adopted a positive opinion by majority (27 positive out of 33 votes) recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable. The Icelandic Member was in agreement with the CHMP recommendation. The Norwegian Member was not in agreement with the CHMP recommendation. The divergent position (Concepcion Prieto Yerro, Kristina Dunder, Jens Heisterberg, Juris Pokrotnieks, Andrea Laslop, Sol Ruiz, Karsten Bruins-Slot) was appended to the opinion. The legal status was agreed as medicinal product subject to restricted medical prescription. The Committee noted the letter of recommendation dated 21.01.2015. The summary of opinion was circulated for information.
Based on past companies think we are looking good but maybe another months wait for the OPINION!!! Fingers crossed!!!
What are your thoughts based on the above?
My sentiment is HOLD as I already brought to many shares otherwise would be BUY
