another cohort. The patients visual acuity tests are showing robust engraftment of rpe cells to bruch's membrane therefore Actc has not only halted the progression of the disease in all three trials but in majority of the cases there is a vision improvement, and not to mention in one patient where there was a dramatic turnaround from 20/400-20/40. Folks, we are at the ground floor of a company that is about change the course of medicine and quite possibly alter human history in a dramatic way that no other biotech company has ever done before. Although actc trails are progressing at a record pace the pps will break your spirits, bashers will create a doubt in your head, the market makers will continue there manipulation, if these trials are successful all the way in there objectives millions of patient lives will be changed in a very dramatic way along with only a handful here that stand beside me as longs will indeed become stem cell millionaires with even a measly 100,000 shares could be worth millions of dollars. The hour of patience it hand October is just a couple of months away and we will not stay in penny land forever, Fda will fast track these trials due to a unmet medical need, JV/Partners will come as these therapies will be worth in tune of over 50 billion plus in just USA, Europe and Canada than you throw in the entire pipeline that Actc has and sky is the limit with this stock as every program in Actc pipeline is worth in 100's of billions of dollar in revenues. The turnaround in pps will be instant and dramatic in fashion and if you are not in right now you wil be left in the dust wondering all your lives what if?
3rd Quarter Call Analysis:
1. ACTC has treated 30 patients now.
2. ACTC to finish phase 1 by end of year and publish interim Data.
3. ACTC hired a new Controller, Kathy Singh got promoted to a new position.
4. ACTC Everything looks great trial progressing as planned 0 safety issues and all patients show sign of visual acuity, not to mention the patient that went from 20/400-20/40.
5. Finally, the words that were music to Ears ACTC to seek breakthrough therapy designation and orphan drug designation from FDA upon completion of phase 1 and than phase 2 will be a Pivotal trial meaning faster to market/ commercialization.
****Sec settlement news will be PR'd right after the settlement occurs***
*****Everything looking excellent and more, keep buying at these cheap levels at the ground floor of a future blockbuster giant biotech ******
Finally, SEC settlement announcement after the close today or next week in conjunction with FDA trail protocol change. ACTC will skip 200,000 RPE cell cohort and head for phase 2/3 with a FDA breakthrough designation. The volume indication that decision is imminent and we will see a knee jerk reaction than PPS will move past .10+ by end of next week.
Will ACTC break the silence at today's CC after the bell? It seems like the calm before a perfect storm of events about to hit the wires..........................................
ACTC trials were designed to test the safety of the RPE cells but the overwhelming efficacy can't be denied, 29 out of 29 patients in ACTC trials have not only shown 0 safety issues but also have gained visual acuity VS. the untreated eye, not to mention one Texas rancher whose vision was restored from 20/400- 20/40(legally blind to legally qualify to get a drivers license) ACTC SMD trials which have orphan drug designation with patients can develop SMD at an early age are begging for a compassionate use program to address this The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health. ACTC RPE therapy qualifies highly under the FDASIA.
Now let's examine ACTC's AMD treatment, AMD by 2015 will become a worldwide epidemic because of the aging population and the overwhelming efficacy demonstrated by ACTC RPE therapy to halt the disease in the treated eye with a single injection and when the phase 2/3 trial endpoints are released you will notice that ACTC and it's OAB will introduce multiple blebs that will just wipe out AMD altogether. ACTC RPE Programs 3 words come to mind "VINI VIDI VICI"
Finally, Only a few longs here with a will that is unshakable will stand with ACTC when it changes medical history!
ACTC SEC settlement finished, nothing can stop the parabolic/logarithmic jump coming. ACTC science can't be stopped now, the medical history has already changed when Dr. Lanza announced ACTC trial patient went from 20/400-20/20, I have not seen that kind of efficacy in any biotech trial ever. ACTC will soon garner FDA breakthrough therapy status and revolutionize the world of medicine unlike any other company in history of the world!
I am patiently waiting for ACTC PHASE 1 TRIAL RESULTS THAT ARE TO BE PUBLISHED IN NEJM, There were several forward looking clues or one can say foreshadowing of things to come and here some that hold clues to why ACTC PPS will shatter through the Maxim group PPS of .45+
1. ACTC OAB meeting was very hush and they did not pump what happened there until even the ASHM but when Gary eluded that OAB is very big and unanimous in them enrolling better vision patients, it was music to my ears because my theory of what happened in the cohort 2A is even more tantalizing than the 20/400 patient vision going to 20/40. I truly understand that them wanting to publish the phase 1 results in peer reviewed journal but when a shareholder asked Gary a question about the cohort 2A patients, Gary side stepped the question and did not answer.
2. My entire investment in ACTC is based on what Dr. Lanza a true genius did in the rodent models, the better vision rodents that were injected had a vision improvement of 100% and if that is what they are seeing in cohort 2A, ACTC will eat REGN and ROCHE for breakfast!
3. FDA was part of Gov't shutdown for almost 3 weeks and now that they are open we should see in coming weeks ACTC getting BREAKTHROUGH DRUG(THERAPY) designation from FDA, FDA is working with ACTC as they had allowed ACTC 10 different modifications to trails and they are aware that they are about to make medical history.
4. FDA is well aware that there is race going on between Europe, Japan and USA and whoever becomes the first will hold the keys to the HOLY GRAIL OF MEDICINE.
Finally, We have indeed the best scientist in the world DR. LANZA and his vision will not only help millions upon millions ailing for these horrible ailments but at the same time set those invested here financially free Forever and ever more.
•ACT’s Dr. Robert Lanza to Deliver Keynote Lecture at the World Conference on Regenerative MedicineBusiness Wire
***Amazing Dr. Lanza keynote after keynote preaching what is coming, but only the blind can see and those who have eyes don't see NOTHING!
The Billion Dollar question I will like to ask The good Dr. Lanza and Gary is if they will announce about the patients in cohort 2A that went from 20/100- 20/20 at ASHM on October.22,2013? or will they wait until phase 1 results are published in peer review journal New England Journal of Medicine?
Now that is blockbuster news that will send ACTC PPS through Maxim target of .45 in 45 seconds but that is material information why would they withhold that kind of information?
Sentiment: Strong Buy