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CK some things that you bring to the board are real and essential to be understood by investors to avoid speculations and false representations. However, you do not know what happen with their financial assets and funds availability. Maybe they have an agreement with a buyer of patents, maybe they will be financed for their clinicals trials. YOU DO NOT KNOW. I dont know either and none of the posters here know what happens.
Also, investors here always wondering about the PPS. WHY? If the shares price keep strong and hold up 6$. What is the problem with this? Ocata is a long investment. It is not like playing with FX or swaps or stock lending, It is a long term investment that will bring money ONLY when the treatment will be approved. So imo, I don't care about the PPS.
Please read carefully the announcement.
Ocata expects to initiate both
(i) its Pivotal program for Stargardt’s disease (“SMD”); and (ii) Phase 2 age-related macular degeneration (“AMD”) trials in the near term, using retinal pigment epithelium (“RPE”) cells. The purpose of the pivotal SMD trial is to determine efficacy and safety, as well as to assess relevant functional and anatomical parameters of cell transplantation using an untreated control group, with the intent of bringing a product to market potentially as early as 2019.
Also, they will not be able to apply pivotal phase II for AMD since it is not a RARE CONDITION. AMD does not have ORPHAN DESIGNATION. Solely Stargardt has it.
That is an incredible new. However the pivotal phase should be solely applicable to SMD since it is a rare disease and shall not be applicable to AMD. But it is the first time that Ocata announces that it should be a pivotal phase II. Strong hope for all patients waiting for this treatment.
Also, imho I do not think that 2019 should be the targeted date for approval treatment in US since FDA is more stringent that ESMA.
But the treatment in Europe shall not be limited to UK but every European countries.
OCAT is on NASDAQ! finally ocata filled a form 8-A12B to announce the registration on Nasdaq starting on february 26!
After three years of her treatment we can easily affirm that the results are not due to placebo effects. It is IMO impossible to keep vision gains for three years solely on placebo effects.
Moreover, the treated eyes of 17/18 patients did not degenerate. The untreated eye does.... For all people in the earlier stage of the disease that is fantastic. We do not care to restore our sight... We have sight... We just want that the disease stop its progression. For all patients in an earlier stage this is a treatment that we are waiting for...
It is 45 AMD patients. Ocata updated its number of patients on December 19 2014.
I repeat... you should really consider to read the documents on Ocata website.
I agree with you on some point (timeframe and that it is not sufficient on the basis of statistics). However, do not forget that SMD is an orphan disease so FDA and ESMA will not require a great number of patients treated since it is a rare genetic disorder which has no cure at this time. 25 is not sufficient but 150 will be largely acceptable.
Also, there is not only ocata and investors who are waiting for the approval of the treatment...
Doctors and patients (the most important thing, the reason why Ocata exists) follow the approval and wait for the possible treatment to be approved....
PLUS - Cataract are normal side effects of SMD and AMD. Patients afflicted with those illness develop frequently such complications.
So Lasers, could you kindly provide me with evidence of your statement? Seriously, you expand rumors since the beginning that I read you. Almost of your statement never occurred. I believe in Ocata but I do not believe in most of your posts that are not documented. I provide you with document published by Ocata on their website and on SEC website and you keep telling everyone that the treatment will be available in 2015-2016!
PLEASE READ THE PRESENTATION OF OCATA!!!!!!!!!!!!!!!! They will only have data for 50 SMD patients 6 months follow-up!!!!!!!!!!
"POTENTIAL EUROPEAN LAUNCH FOR STARGARDT'S MACULAR DEGENERATION IN 2019"
http://ir.ocata.com/sec-filings?page=2#document-27014-0001104659-14-087951
It is for that reason that I begin to read Icell... More realistic data and posters!
Lasers. Even OCATA provides possible approval treatment SOLELY in Europe in 2019. Ocata NEVER STATED that the treatment will be available in 2016. They will only have data for 50 SMD patients with 6 months follow-up in Q3 2016. That means that your previsions are unrealistic.
Please take a look at the related document of December 19th 2014. You will clearly see that the potential lunch for SMD is 2019 in Europe.
http://ir.ocata.com/sec-filings?page=2#
I understand your point of view. And It is true they have still a long path to do. However, if they survive at Phase 2 they will get helped by government and FDA to get their treatment approved for people in needs. I am more realistic like you about all the work they have to do. However since it is my treatment to get a beautiful life (not for money but only to have normal vision!!!!) I strongly believe in OCATA. And I am convinced that they will succeed! But I know that we have 4-5 years before that success. Sincerely I do not care about money... I care about my eyes and many patients are waiting for their MIRACULOUS treatment.
Posters should stop to speculate on things that they don't know. First of all : there is only 8 patients with better vision cohort (4 SMD and 4 AMD in USA ONLY) UK did not go through best visual acuity cohort for their SMD trials yet.
Secondly: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000296.jsp
There is nothing in the description of ATMP which provides a fast track designation to get an earlier approval. The ATMP designation only provide new methodology of evaluation as well that scientific experts advise. Stop to speculate on something that does not exist. Fast track and AMTP designation is clearly different. And there is a lot of biopharma who get this designation and they are only in phase I study. You should google it.
Third: Ocata clearly stated in their documentation that the SMD treatment will only be approved in 2019 IN EUROPE ONLY. It is impossible that they approve treatment with only phase I data. And what do you think? the ophthalmologist are all waiting for treatment because currently they only tell to their patient wear sunglasses, do sport, stop smoking and dont take supplement of Vitamin A. If there is an approved treatment with strong data of effectiveness and safety they will all prescribe this treatment. How they can earn money without treatment? I do see my doctor with a follow-up only once by year and it is paid by the Assurance-Maladie of Quebec.... He doesnt earn money!!!!!
You should maybe take a look at sparks therapeutics. They took 9 years to prove the efficiency and safety of their treatment, they are in phase 3 and they just receive last month the breakthrough designation from the FDA... so please... why Ocata should be treated differently!!!!! Sparks therapeutics provide a treatment for a rare condition of children blindness!!!!!!
Finally, I have SMD. Do you think that I do not speak to Ocata... When you give the name of your doctor, your gene test proving that you suffer from SMD... They give you some details. Not the results but they give you some information about your expectations. And they clearly told me that I am not elligible right now and and for the next 3 to 4 years. My visual acuity is 20/25... And you think that you will have an approval in 2015?? Posters who know my real name should go take a look on my linkedin... They will see who I have in my contacts..... Lanza and Wotton...
Also, I spoke personnaly to Maurie Hill. She gave me a lot of information about the disease and hope to my future life... But even if I asked some question about stem cells, she never get me back with answers... She only focussed on my future life and what will be the progression of the diseaase... Wo where did you find a statement from a patient who tell that they want their second eye treated? They execute an agreement which specifically indicate that they are in clinical trials and they will have only one eye treated to monitorize their improvement!
I truly believe in OCATA but again here poster should be realistic... It is like the NEJM and Big pharma speculation... It is only SPECULATION!
I think that the efficiency data will be better worth with best visual acuity. Ocata hopes to treat earlier stage of the disease and I easily understand the importance to differentiate people who lost their photoreceptors 20 years ago and children who are at 20/25... However they cannot treat such people without proving that the magic cells make not patients loosing their sight! Ocata is a long investment. You cannot expect to get revenue from this stock until 4 or 5 years. However, you participate in the revolution of the medicine! SMD patients are waiting for the treatment.
However, an important point in finance is to diversify your investment. You never bet on only one stock... Also you should never make a debt to invest....
Lasers. That is clearly impossible. The approval of SMD treatment will not occur before 2019 (at least). Ocata needs more data and evidence of long term safety of their treatment. Doctors will not prescribe such treatment until they are convinced that the treatment is effective and safe. I do not want that people believe that the treatment will be commercialized in 2016 because they will have deception. I want more than everyone here the treatment available for SMD patients but my hope shall be realistic and I think that should be the same for investors. I respect all the information that you bring but 2015-2016 approval is impossible.
Unfortunately, investors shall read the SEC definition of quiet period. Ocata has the right to disclose any material information right now. I sincerely believe that Ocata will uplist. However, please investors you should be careful to be not misleading by false information... The creation of false hopes will make you angry on monday if nothing happens...
Please read the SEC notes posted by Hopalongstock.
http://www.sec.gov/answers/quiet.htm
For my part, even if the uplist does not occur monday, I still believe in the management and the science behind... all everybody knows here! Go ocata!
Thanks to all for your support Farviewhill, anselab, art2426 and runcaly.
I would like to add my personal perspective. I am now part of a group on Facebook for support with people afflicted by Stargardt. As I can observe, everybody in the same situation as mine (still with perfect vision) are hoping to be treated by Ocata in the near future. Ocata gives hope to all SMD patients. Hope to seeing the world tomorrow. Go Ocata... give us our treatment!
Very Good news this morning. Look at the exchange for OCAT: NASDAQ.
Tomorrow the uplisting will occur.
http://www.nasdaq.com/symbol/ocat/real-time
ACTC updated the outcome final data date for the US SMD clinical trials website.
Is ACTC treated his last patient????
http://clinicaltrials.gov/ct2/show/NCT01345006?term=NCT01345006&rank=1
ACTC will host conference call on monday.
http://ir.advancedcell.com/press-releases/detail/2634/advanced-cell-technology-to-host-conference-call-and
I am disappointed to see how Foundation Fighting Blindness Canada and FFB USA treat differently ACTC results. FFB Canada seems happy and spread the new. FFB USA seems to oppose to the results and mentioned placebo effect.
Seriously. the only reason which I found to explain such discrepancy between the two foundations is political... and NOT science efficiency....
I love to read such article. Give hope to all people afflicted by horrific disease such as Stargardt.
http://www.ffb.ca/research/research_news/interviewKhalili.html
You are right. It is impossible that those requirements apply to me. I am only at 5 letter to the perfect vision. I cannot improve of 3 lines (15 letters) it is totally impossible.
20/200 to 20/50.... It should be miraculous.
I am looking forward to see the results of better vision patients.
Did you ever see this statement before? (3 lines)... Looks like that the halt of the progression of the disease will not be sufficient... Seriously I just do not understand what is those criteria....
Art 2426. I have been diagnosed with Stargardt Disease and I totally agree with you. If ACTC treatment halts the progression of my disease I will take it without any further concerns and enjoy the rest of my life with good vision. I do not understand FFB statement. There is no treatment so if they do not restore sight a treatment which shall stop the progression of the disease.... IT IS A TREATMENT!!!!!
I think that FFB has some issues non-revealed with ACTC.
They are supposed to help me... not to destroy hope.
Foundation Fighting Blindness: Since when FDA needs improvement of at least three lines to approve the treatment?? If patients stay stable, it will help everyone in the earlier stage of diseases....
http://www.blindness.org/articles/stem-cell-derived-treatment-retinal-diseases-safe-thus-far-human-study
Lasers. I really respect your opinion and all the important information that you bring to this board. Unfortunately I do not agree with you on the earlier approval. ACTC will take 150 patients - 50 patients SMD in the US - 50 patients SMD in the UK and 50 patients AMD in the USA.
I don't think that it will be a faster approval since they will need more patients to complete their statistics. Also, it will be unlikely that ACTC will treat excellent vision patients (early stage of the disease) in phase 2 since they will not put in danger the good vision of someone. AS I explained in my other posts, Phase 1 of SMD will stay stable for 10 years + without progression of the disease. ACTC will likely wait to obtain more results before treating such patients (like me...)
I guess we will be able to provide more information on the approval when ACTC will publish their criteria for the new enrollment.
Hope I am wrong but I prefer to be realistic. I believe totally in the treatment of ACTC but they need statistics and time before the approval. And I am pretty sure that the Phase II results will be the same as phase I. Miraculous.
Yes. We shall be realistic. JV or partnership will occur later in the process since big pharma need more data and statistics before investing in their treatment. The only mean available to ACTC to keep doing their clinical trials is by dilution. You are investing in biotech. You should be aware of the risks. But once they get FDA approval, you will earn worth from your initial investment.
They will not get faster approval since it is completely new treatment. Genetic treatment went to all the phase before getting their approval. It will be the same for stem cells.
no one restored sight before. Could you imagine how it is miraculous?
Fulleroots. Do you know what is the average salary of doctors in United States (I am Canadian but I expect that is 400 000 +++) and this is their salary. The average doctor salary. Do I am wrong??
As I am a stargardt patient, I am asking you all to keep your faith in ACTC. It is completely miraculous. I have strong hope that they will treat all of us....
Shareholders do not appreciate dilution. But what is the best for you? To get a portion of 1 or 2% of billions dollars or to keep your investment and loose everything since they need funds to go through clinical trials.
I do not understand how a really good new with POSITIVE results make shareholders disappointed.... THEY RESTORE SIGHT AND STOP THE PROGRESSION OF THE DISEASE. THIS IS COMPLETELY AMAZING!!!!!!!!!!!!!
Shareholders. Please stop thinking that ACTC will have a treatment in 1 or 2 years. That is impossible. You should ask to every doctors they will tell you. They need more data and patients to do statistics. And to complete their clinical trials they need money. You have still a long ride to do before commercialization but AMD and Stargardt patients need you.
ACTC announced miraculous results. Never someone restored sight to nearly blind people before.
Be patient...
The new is even in Quebec.... I just do not understand this pps going down.....
http://ici.radio-canada.ca/nouvelles/science/2014/10/15/001-cellules-souches-embryonnaires-cecite-resultats-prometteurs.shtml
Important! ACTC prepare to release the shares to Lincoln.
Please refer to the Form S-3 filed.
http://ir.advancedcell.com/all-sec-filings#document-25784-0001019687-14-003858
REALLY GOOD TO SEE THE MAX PRICE! 20$!!
Many thanks Anselab.
You are right. The photoreceptors program will save millions of people with RP, SMD, AMD, Leber, Glaucoma. That will be fantastic to all those people waiting to see their family, to read, to drive, to travel and to keep their independence and mobility. Fortunately, RPE cells will help SMD and AMD patients to wait until the succeed of this treatment. And hopefully, we will not even need the photoreceptors since ACTC will give us the wonderful gift to stop the progression of the disease. ACTC is wonderful as well as all investors who believe in them.
if I believe your profile you will be 70 years old! But I think my time frame is realistic since actc is dependant of FDA.... FDA need data! and that need time. just to enroll patients as well to prove the safety and efficiency! but when they will succeed actc will be the first company ever to show the miraculous power of stem cells.
you will save people younger like me (29 years old) with your investment :))
I will be so much happy to see a faster approval. I think you are right about the engratment. Maurie Hill talks about it and shared that the cells engrafted into its retina..that is a very good new and I hope that it will be the same case for every patients. The tumor neved developpee. I asked to doctors how long a tumor can develop. they told me 1 year or 2. that a great new since it will be faster. I am really excited to see the results about the patient with better vision. those results will prove the efficiency of the treatment... maybe in one or two years we will have all our answer. Hopefully all posters here will be right and that will be faster than the average clinical trials... only years will tell us... actc will be the future. we just dont know when....
my last inquiry... i emailed doctors in pensývania... they do not answer to me... smd is a rare condition... I think they need people like me... but I asked question like when will you treat people like me (20/25) .... i hiven the name of my doctor and the result of my genetic test.... I will hapy to share with you all my information that i will try to obtain.
keep your patience.. actc is revolutionnary...
Last UK patient who provide information on the trials.
http://www.ub40.co.uk/forum/general-anarchy/612838-where-do-you-stand-advances-stem-cell-medical-advances-4.html#post1656479
I took this link from an other forum. The follow-up as well as the entire tests look painful. But he is really courageous and will help to develop the revolutionary treatment.
Farviewhill. I really hope that you are right. IMHO the Phase II will be faster than the Phase I since the safety will be proved.
The FDA has very high standards to assure that the treatments will be efficient as well as safe. Since ACTC is new and we do not know what will be the body's reaction (so far IT IS VERY GOOD!) I think they will be prudent and collect data.
Also, I am wondering about the enrollment. Since SMD is a rare disease, it will be hard to find patients as they are looking for (20/400 - 20/100 and maybe someday 20/40). The disease will vary for every new patient (children vs adult). I hope that the enrollment will not be fastidious. (no worry with AMD though).
With your experience, did you see a lot of new biotech who get their FDA approval faster than 8 -10 years?
Hope you are right on this point....
Daveds. Unfortunately IMHO ACTC will need at least 5 to 6 years to go trough Phase II and III and commercialization. I based my opinion on my doctor (he told me that the treatment will be available to me in 10 years) as well as the average time frame for clinical trials to complete their research (10 to 15 years). Since it is a completely new treatment (revolutionary as well) FDA will need to compete all the date necessary to ensure that it is safety. I really hope that it will be faster but I do not think that will be the case. ACTC is not a short term investment. It should be a long term.... but a long term investment which will be worth!
I totally agree with you Farviewhill. There is no partnership concluded since it is a material event which shall be released by ACTC. Shareholders do not want to dilute the company. I can understand. But if they do not dilute they will not be able to find the funds for Phase II and III. ACTC has at leat 5-6 years to go prior to commercialization of the RPE cells. They need money.
So what do you prefer: loosing your total investment because ACTC is not able to handle the Phase II and III; or Dilute to get a lot of gains after they succeed with the commercialization?
ACTC is NOT in NEJM October 9th publication