Safety is obviously not an issue. Cohort 2a will allow us to show efficacy in our target market. We are only need 60,000 cells to attatch in order to resurface the Epithelial layer; our 100,000 cell injection is more than adequate and we have photographic evidence of attachment. If 3 out of 4 of these 20/100 patients show some improvement, big pharma will be begging us for a JV. (Position of strength)
Cohorts 1 and 2 in Ph. I/II were originally planned to be part of the safety trials; but, as we all know, it has surpassed that goal with Cohort 2 and has become effectively an efficacy stage. In other words, the big pharmas looking for partnership with ACTC has enough evidence to enter into the partnership because they normally wait till safety stage is successfully accomplished and efficacy stage is anticipated to be as desired. However, I believe, while GR taking this argument to advance his expedited search for partnership, would certainly wait for the final deal until results for Cohort 3 (150,000 cells) are available to gurantee efficacy further and enough data is obtained for early-stage patients just included. Also, a larger patient base would be preferred by the prospective pharma to establish wider safety and efficacy base, which they may jointly do before finalization of the deal.
In any case, the "unmet need" situation is an important reason for the FDA to allow accelerated trials, especially since no serious safety issue existed with the treatment. I think we are in a very critical but important stage right now and unnecessary haste resulting in less than an optimum deal would be unadvised. I believe that is what the company is trying to do; i.e., wait for the right time to enter into the deal which may be after at least getting needed data for Cohort 3 and for the early-stage patients.
Sentiment: Strong Buy
Yes, I must add that it is also premature to enter into any partnership deal until the share price is raised to more reasonable level so that a better offer can be squeezed. Would that be achieved if RS and NASDAQ listing are accomplished and institutional ownership is raised substantially as a result? Perhaps. But, you can see that GR is perhaps facing these issues and being a poker player will be helpful!!
Sentiment: Strong Buy
Cjenn, that would be great, but I really doubt ACT is pursuing a JV with big pharma at this late stage in the game, because they've done it alone this far, so why let someone swoop in this late in the game and steal all their glory and profts.
GRs bonus this year it tied to a JV...there will be one. We are passed "safety" issues. We will get fast tracked for SMD in Europe first, then for SMD in the US. That will provide revenue and a share price jump in anticipation of a JV.
You're nuts! It's too early in the game, not too late, for a JV. Big pharma has never JV'd during phase I of any trials that I am aware of. Can you show us where they have? ACTC is in early stage phase I. What are you guys smoking?
I appreciate the thoughts.
Undoubtedly Cohort 2a will help to establish the best path for the next Phase of the trial. Whether it is called Phase II with new primary endpoints based on the results of Cohort 2a or called a Phase III, I am not sure. Either way, I believe this new cohort will prove valuable in expediting things.
Gary Rabin and Matt Vincent have made it clear though that there are still many questions that need to be answered and that it will take time. They are in no rush. A JV could have probably happened by now, but Gary has said he wants to wait until they have more data and further endpoints are established.