RE: Any thing newHello Bioboy:
I don't have answers to your questions but let me give you perspective:
A reasonable deal is the only event that will get the SP over the mark you’ve stated. While the 1-year out data will help the SP, there are other events prior to that that may help cement a deal.
Someone that attended the AGM told me about the steps currently underway leading up to Investigational New Drug (IND) status. The IND flows out of the end of Phase 2 meeting with the FDA. One missing piece is the manufacturing process. At the AGM, PRX said that this process was underway and would be completed in or about the September time frame. Documenting the production process involves producing commercial size batches and doing accelerated 3-month stability tests. Once this data is in hand PRX can move to schedule the meeting with FDA.
The meeting with FDA will review the Phase 2b data, the safety profile and manufacturing process and stability and PRX and FDA will come to an agreement as to what Phase 3 results would result in FDA approval.
Similar meetings will take place with the EU.
Once the parameters of Phase 3 are known, the likelihood of a deal and or the cost of proceeding without a partner to accommodate either or both FDA and EU can be made by PRX.
The 1-year out data should be available about the same time as dialogue with the regulatory bodies. The next $5MM progress payment from Kissei may fall in or around this same timing – i.e. year-end.
It is difficult to speculate on the year out data, but the company will be able to keep a running score, as the code has been broken – so they will know each test recipient results as they become available. This early window together with positive initial dialogue with FDA/EU may provide the catalyst fro a deal. BTW, I expect 1-year out data to show continued improvement in the test cell and continued deterioration in the control arm.
Net, net Bioboy, I do not expect much any earlier than the 4th quarter, but realistically the 1st quarter of 2011.
The market expects clarity on funding for Phase 3; until that can be provided we might see gradual creep up towards or into the 50 cent range - but no more imo.