1. CBER has awarded a Breakthrough therapy to ACTC back in October after the OAB Unanimous positive vote on ACTC RPE cell therapy, Here is a quote from the FDA website:
3. Cohort Size
For trials that enroll sequential cohorts with dose escalation between cohorts, the cohort size should depend on the amount of risk that is acceptable in the study population. Smaller cohorts might be adequate for a product that is intended to treat a life-threatening disease where a greater potential benefit may justify a higher risk.
4.Operator Training and Documentation of Procedures
For product delivery that involves a complex administration procedure or a device requiring special training, such as subretinal injection or use of specialized catheters for cardiac administration, the skill of the individual administering the product can impact the product’s safety and efficacy. When individual skill in administering a product may affect its safety or effectiveness, the trial should specify minimum requirements for the operator’s training, experience, or level of proficiency, prior to participating in the trial. In some cases (particularly, if there are multiple operators), training of operators on the specific administration procedures may reduce variability of administration and thereby improve interpretability of the study results.
2. Disease Stage or Severity
For example, the risk of a decrease in visual acuity might be more acceptable in a subject with some visual reserve than in a subject for whom that same decrement might result in loss of all functional vision. Although subjects with more severe or advanced disease may have the greatest need for benefit, there can be situations in which a greater potential for benefit might be expected for subjects who are less severely affected. Further, the ability to detect evidence of any benefit could depend on the severity or stage of disease in the study population.
**ACTC getting the house in order before PR***
Dr. Tony Montello
Sentiment: Strong Buy
Hey Tony, as you know, ACTC management including the New CFO are finally closing the messy mambo jumbo of past CEO William M. Caldwell IV, and bloopers of GR, for not reporting his stock sales in a timely fashion.
By submitting the 8K form, the ACTC management team are finally starting a new beginning by restating the financial statements. And, in my opinion, next PR statement will state the fact (ie. the restatement of the financials) BUT most importantly, the will be provide extremely exciting news of their ongoing Trials developments plus new discoveries. :-) Good Luck. And, frankly, I'm waiting for ACTC to start a partner program with Big Pharma. In any case, they sure need it because they can't commercialize the stem cell therapy w/o the financial backing (deep pockets) of the Big funded companies.
Sentiment: Strong Buy
Have read your horseshit post for years ...you have never been right once...once...even a broken clock is right twice a day..dr tony montello is probably a part time walmart employee who abuses prescription drugs and lives in a van
by edhelms35 • Dec 26, 2011 12:56 PM Flag
I pray everyday the technology works in order to help my wife regain vision
special ed can your wife still read his posts? You don't seem to care about her or the technology anymore : )
Well Anthony maybe if any of your PAST PREDICTIONS would have been close to being correct someone would heed your posts, however, your creditability in this area are non-existent. I have been an investor in ACTC since 2007 and I have seen plenty of PAID PUMPERS like you and fighterpilot & PAID BASHERS like edhelms and bearclaw, and all your non-founded unsubstantiated posts do is serve as fodder for the Naysayers, just look at bearclaws demeaning posts of you and fighter pilot. You are better off going to some other board to posts and earn a few bucks, your M.O. is obvious here, just as bearclaw and edhelms is!!
Re: .... PAID BASHERS like edhelms and bearclaw ......
Think what you want, makulski, but you're inaccurate. I do not receive monetary payment.
Re: ......... just look at bearclaws demeaning posts of you and fighter pilot.....
I merely posted their messages, including the injun. It's their own words....... unedited.... nothing taken out of context, no distortion, and no misleading as the führer accuses me of doing. Actually, it is the führer , who is guilty of 'severe misleading.'
fighterpilot • Feb 10, 2014 2:03 PM
Just stay away from this bear jerk with his UNIQUE CUT AND PASTE skill which in context amount to severe misleading.
fighterpilot • Feb 10, 2014 2:22 PM
YEA and he fully knows in which context of the Lancet publication my 20 cent post was written and that it was before the Lanza selling and the lawsuits . And this list goes on and on. Out of context distortion with cut and paste. He is a despicable dishonest jerk. Stay away from him.
Re: ...your M.O. is obvious here, just as bearclaw and edhelms is!!
I'll gladly pay you next monday for a melt in your mouth.... almond bear claw pastry today.
I agree 100% with your assessment:
How would this be for drama? Interim TLD announced Wednesday evening. Then Thursday PR that financials will be released at the close of the market with a conference call that evening. In the financials we essentially reset the number of shares that A/G asked for and they agree to dismiss the case. The management at ACT has pretty much announced a negative right before a positive fairly consistently.
Sentiment: Strong Buy