The timing of this oral CHMP presentation looks strange. If they have more data available in March, why not wait for the additional data and then present? Are the data same drug and same indication/disease?
While I agree that there are some sizable unmet needs there, I do think that because there isn't really anything out on the market to treat the disease that there might be enough justification to approve it. The harmfulness of this drug doesn't seem to outweigh the benefits of taking it. I might be off base on this so please feel free to correct me. I welcome a good conversation.
I didn't listen to the conference, but just found their slides from the presentation on their website and have read through them. I found most of the presentation very informative and enjoyed seeing a more robust update on pipeline activity.
The only concern that I had was on slide 23, which looks to be the primary basis on which a decision will be made. It appears that the unmet needs outweigh the positive results that have been found. In the slide before that it documents that conditional approval has been granted at a ration of 1 for every 5 since 2006.
There's lots of positive and details in these slides, but just wondering if there should be any concern in the short-term with respect to the approval. Perhaps not getting the prelim approval and being asked to go back and get further support/documentation. Any thoughts?
The basis for their EU application is the platinum resistant ovarian CA data. The slide you are referring to discusses the NSCLC trial. They switched diseases between slides 22 and 23.
The conditional approval has always been a bit of a long shot because they are going in with phase 2 PFS data. They have not shown an OS benefit (yet?). The upside is that the PFS data does look good (to me anyway...) and the EU has given conditional marketing approval to drugs on the basis of PFS benefit before, so there is precedent for this ;)
I listened to bits an pieces of it over my Samsung Galaxy S3 mini while at work. I heard that bit about 80% of the patients staying on the monotherapy arm as well and thought the same. To me that is a pretty positive indicator. Have to wait and see and hope the results are good.
On the volume note, we two days of over 1 million shares traded and today wasn't bad with over 400k. It's good to see the north east trend. I hope it can keep going.