Friday, August 30, 2013 11:32:12 AM
Post # of 55318
Food for thought.
(See last linefor author)
Thoughts on ACTC for the next 9-12 months
I wrote this e-mail to friends and family who are either already invested in ACTC or thinking about it. As you may be able to tell I used many others Icell posts to formulate my opinion.
My thoughts on ACTC,
I am going to give my prediction of what I expect from ACTC for the next 9 to 12 months. I wanted to try and line up what has been stated by ACTC with their actions and make a timeline on possible outcomes. Much of this is direct statements from the company, the rest is my opinion and speculation.
Up to this point the trial results have been outstanding. Besides the 20/400 patient that was reported having their vision go to 20/40, 24 out of the 26 patients that we know of to date have had their vision loss stopped and in may cased visual acuity has been seen. Because the progression of the disease and loss of photoreceptors in the original set of patients the doctors did not expect any visual acuity. This was a phase one trial for safety. There have been 0 safety issues an no reports of side affects(unheard of in drug trials). Because of these results the FDA allowed for a set of better vision patients (20/100) to be tested. These patients still have most of there vision so this also was unexpected and an exception to the rule. All this for one of the largest unmet medical needs in the world estimated to cost 30 Billion dollars a year and growing.
Gary Rabin 2013 2Q CC: "I would like to take this opportunity to bring everyone up to date up on the exciting progress in our clinical trials. As many of you are well aware, we have been very surprised by the results of the treatments. We certainly did not expect to see visual acuity improvements in anyone in this patient set. We were resolute in our belief that there wasn't the possibility of rescuing photoreceptors at this disadvantaged...
Having completed the triple cohort the ball band has tightened on the rectina and the dry amd rpe cells are leaking phosphate c03. Trials are ongoing so keep buyin more so gary can buy another home in Europe.
part 2) of the disease. We are now rapidly approaching the completion of the third cohorts of all three clinical ..trials to investigate hESC-derived RPE cells for the treatment of dry AMD and Stargardt's macular dystrophy in the US and Europe. We continue to run our trials in the best ophthalmic hospitals in the US and the top eye hospital in Europe, and are continuing to draw the attention of leaders in the field. We are excited that we have received approval from the DSMB to complete testing on the third cohort of each of the three clinical trials after an interim review by the DSMB conducted six weeks after the first patient was treated in the third cohort of each trial. The DSMB has not had any concerns which would impede the study. In what we consider to be a resounding endorsement of the safety of our therapy, the FDA and our Data Safety Monitoring Board allowed us to treat patients with better vision as good as 20/100. These patients are likely to have more photoreceptors that can be rescued. We remain CONFIDENT THAT ALL SURGERIES ON THE REMAINING PATIENTS IN THIS GROUP WILL BE COMPLETED IN TIME FOR COMPLETE DATA REVIEW AT THE COMPANY'S OPHTHALMIC ADVISORY BOARD MEETING IN EARLY OCTOBER. This October meeting will be a chance for the company to gather with its world-renowned panel of experts around the data generated to that point. We believe this meeting will be an opportunity for us to really hone in on several strategic elements of Phase II design. We're excited to have access to the key opinion leaders in the vitreal retinal field to help us map out our path to commercialization. We have observed no significant safety issues relating to the treatment, and the DSMB has approved each planned step in the trial, as well as the treatment protocol for patients with better vision, WHICH IS NOW APPROACHING COMPLETION. We have observed the PERSISTENCE OF VISUAL ACUITY GAINS and the engraftment of the transplanted cells in both the SMD and AMD patients, which is...
...consistent with what was previously reported early on in the trials. We just most recently treated our 26th patient. A critical part of our evaluation is to further clarify what factors will help us to identify the patients who will benefit the most. The clearance to complete treatment in patients with higher doses of RPE cells and patients with great visual acuity represented significant milestones in our clinical trials and we will be excited to share those results as soon as possible."
You may be aware that ACTC just put out a proxy to do a reverse split it order to uplist to NASDAQ. “We believe each of the proposals submitted to our stockholders at the 2013 Annual Meeting are necessary steps in our previously announced plans to up-list our stock to a national stock exchange,” said Gary Rabin, ACT’s Chairman and CEO. “The upcoming months should be a period of significant value creation as we announce data from our clinical trials, and we want to position the company so that these results receive the maximum exposure in the investment community. We believe that our current corporate structure is an inadequate representation of the tremendous business prospects that ACT carries. We are pursuing large unmet medical needs with a game-changing therapy and we believe that having our stock listed on a national exchange will enable a broadening of our shareholder base to include long-term, institutional investors who can support our current, and future, clinical programs. ”
This is something we have been waiting for. But one issue that will need to be cleared up before uplist is the resolution of the SEC lawsuit. That alone should be a boost to the price per share. In the recent conference call Gary Stated "in terms of the uplisting, obviously that's part-and-parcel to the SEC settlement; but, we have been working very diligently with the SEC, making progress. Obviously it's been slower than we hoped, but we feel that we are heading in the right path. We...