I agree with you, I would be surprised if there was negative news from the EMA, especially with the PDCO recommendation.
People, let's not forget that ANP has been collaborating with PDCO on the PIP submission, it's not as if they just submitted the application out of nowhere:
25th Feb: PIP was submitted to the PDCO for feedback;
22nd June: Feedback received and in-line with expectations. No changes to the key features of the study protocol however PDCO has some additional information requirements which ANP were preparing responses to. Nuket Desem from ANP noted that "We have appreciated the collaborative approach of the EMA to assist us in refining the study design for the proposed Phase IIb clinical trial in Europe".
30 September: Draft opinion recommending agreement on PIP received. Note that as part of that announcement ANP highlighted that they will provide further details on the trail design, timing etc when the final opinion is received.
As the latest Corporate Connect Research Report highlights: "This is not a final decision but we understand that it is very unusual for the EMA not to adopt a recommended PIP". Note that this report is authored by Marc Sinatra who has worked in the life-science industry for over 25 years which included being involved in clinical trialing and regulatory approval; we aren't talking about a fresh uni grad writing up this report.
IMO the trial approval is almost a given. I am more interested in the details of the trail and the funding arrangements.
ANP Price at posting:
29.5¢ Sentiment: Buy Disclosure: Held
