Hello everyone, I attended the Sydney presentation today and honestly, it was a little disappointing to see no more than 20 people at this presentation. I hope it is a sign that people are confident in the companies progress or it may be that there are a lot monitoring HC and feel not need to attend, lol.
I won't go over old ground which has been raised, but will add a little information which may clarify some points that have been raised. My questions to ML were:
Q. Clarification regarding CAN-004 top line data due in 2015 and Cvac commercially ready in 2016. Will the USFDA being ready to approve Cvac by this time or will the process of USFDA assessment just begin and how long is anticipated that this will take?
A. ML stated there is communication during the trial and that there are generally three areas which the USFDA will assess a treatment, safety (early trials will demonstrate this), manufacturing and efficacy (success in life extension, i,e, primary end points etc). Usually, the first two areas have already met the USFDA standards by the time final efficacy data is presented. So, by the time Canvas is complete and data presented it is just the efficacy (final stage) to be assessed. Communication with the USFDA during trials is very professional and official, with the USFDA visiting manufacturing centres, hospitals etc etc. to see for themselves what is happening.
(Further and most importantly, ML stated that although some 800 patients are to be enrolled and some 100 to 120 hospitals brought on board, usually the USFDA approval process is commenced after 400 patients have relapsed. An analysis of the data is then commenced and presented.
I found this extremely interesting, as it brings the timeframes mentioned by Prima into alignment, more so than I previously expected, considering the rate of patient enrolment)
Q. Would the TGA (australian equivalent of the USFDA) approve Cvac prior to any Phase III results as Cvac is a blood product.
A. Although Cvac is made using an individuals blood there are dozens of other substances which go into making Cvac. One of these is Mannan Fusion Protein, which negates Cvac being completely a blood product. Therefore it is unlikely, it is also unlikely that if this road was attempted it may be negated by the treatment not being included under the PBS.
Q. As the Cvac patent expires in 2018 and the Mannan Fusion patent expires in 2014, is there any impact on the Orphan status, which extends exclusivity for a treatment upon commercialisation.
A. ML stated that the USFDA gives an undertaking not to approve any other treatments when patents such as in the circumstances of Cvac already exist. Further, if trials were to be delayed and certain patents expired before commercialisation, Orphan designation still applies. ML further explained that Prima are not required to publish any information regarding the 'ingredients' in Cvac, how it is produced or any other data relating to its development and use.
(I was relieved to find out that if there are delays, such as occurred with Provenge, that Orphan designation and the extension in exclusivity still applies if patents have expired prior to approval)
Q. What is the likelyhood of a takeover prior to or instead of any licensing agreement.
A. ML stated that big pharma's are usually very conservative in this area although they also hold a large amount of cash. He further stated that usually a licensing arrangement is agreed upon first, then after a period of time an assessment may be undertaken of potential revenue from extended product lines. After this is done, and a positive assessment/analysis is made, a take-over may then be made. ------------------------------
I have been to these before with MR presenting, and as others have mentioned ML is much more reserved in his presentations. Others at the meeting today remarked that Prima is not promoting itself or Cvac well and that milestones should be announced with more enthusiasm. It was mentioned that it appears the management have big plans for Prima, with manufacturing centres organised and the ability to scale up when commercialisation comes, but these 'dreams are not being conveyed to the public/media/analysts etc. I thought this was a very good point.
A couple of things I took from this presentation were: 1. I believe they are planning to use Prima's current technology and production to possibly work with other companies who have their own treatment/product/patents as a means of generating revenue. I believe this was mentioned in another PRR thread on HC, and think it has merit. Prima a very proud of their collection, manufacturing and logistics processes. They already have a lot of the elements of Cvac produced and cryogenically frozen, ready to go. They may feel they have the ability to earn revenue without impacting on Cvac production.
2. I was interested in ML's explanation of licensing arrangements proceeding a take-over. It was my observation during informal discussions with ML after the presentation that prima are VERY open to discussion on any avenue which will bring Cvac to market as well as benefit shareholders. i took this as ML and the board would not stand in the way of anything which would benefit Prima for their own personal gain.
Therefore, I feel that they are waiting for Can-003 results to then proceed with a licensing arrangement using this data to negotiate the best deal possible for Patients and shareholders. During this Prima will continue with their spin off trials involving other mucin-1 cancer types in hope that it will result in a full takeover. This is just my opinion.
Another interesting point, is that the enrolment process for Canvas begins when the disease is first diagnosed. This means that all enrolments for canvas must begin with diagnoses. The patient is then enrolled, with the process of surgery (debulking - conditional that less than 1 cm of tumour remains), chemotherapy and then remission, at which time Cvac is administered. It is apparently important for the whole process to be monitored under the trial. So any patient already diagnosed AND treated (surgery and/or chemo) prior to being introduced to Prima cannot be enrolled in Canvas.
I hope this helps (hopefully not too many typos etc etc), regards and good luck to all.
dc
PRR Price at posting:
9.3¢ Sentiment: LT Buy Disclosure: Held
(20min delay)