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• Neurotech's Fast Track
• Posted: 2009-01-13 18:45:15 By Luis G
• Hey, did you already realize that Neurotch's ECT have received fast track status from FDA???
  
  Could you please tell me what does it mean and???
  
  It seems to be a great new, but what do you think??? Any idea of the price?
  
  Greetings,
  
  Luis G

• Posted: 2009-01-13 23:27:35 By Darran Z
• Luis,
  
  This has always been the case. What they mean by "fast track" is that Phase 2 and Phase 3 are combined into a single study instead of having two separate pahses, the FDA requires 3 phases of studies, but since the 1st phase came out well and unexpected positive results and that there currently is no treatment for RP, the FDA approved this fast track appraoch.
  
  The study will come to the end this year. But it will take another year or two (or more) to compile the data and see whether it will be approved or not. From some of the other lists I'm on, it appears the success is a hit or miss across the board. So whether it really does anything, is to be seen in the final report.
  
  Darran

• Posted: 2009-01-14 11:07:02 By Luis G
• Hi Darran,
  
  Ok, but look what the new says (taken from the main page of this site):
  
  "Also, the FDA will review an application for marketing approval of a Fast Track treatment within six months. Neurotech plans to release results from their three Phase II/III clinical trials in spring 2009. At that point the company may seek FDA marketing approval for the treatment to make it generally available and/or conduct additional clinical studies".
  
  I understand that Neurotech will present final results within the next months. Last two sentences states the possible marketing approval by the FDA AND/OR the conduction of additional clinical studies...it may take some time. If the FDA does not require any additional studies and approves the marketing then the ECT could be available sooner.
  
  As to the success of the treatment, is it questionable? What is the worst case you know?
  
  Greetings,
  
  Luis G
  

• Posted: 2009-01-14 13:48:47 By Darran Z
• Yes, I understand this. Remember, Phase 1? It took them a couple of years to get that compiled and published and there were only 10 participants. Why did it take so long? They were short financially to move along.
  
  All they are trying to do is take short-cuts. But what happens when short-cuts are taken? Remember Vioxx? That was "fast tracked" as well and it ended up being taken off the market. So I'm a bit suspecious here.
  
  As for the "worse case" situations, some people report no change. The side effect of constricted pupils are common. Some peopel did see improvements. But the question is, will the results be significant enough to market it? I think people, including Neurotech may be jumping the gun here without getting the results done first.
  
  Darran

• Posted: 2009-01-14 19:06:14 By Luis G
• Well, I guess I've been too optimistic.
  
  Luis

• Posted: 2009-01-15 14:49:47 By Darran Z
• Luis,
  
  It's not a bad thing of being optimistic. I've heard this same tune "well have a treatment within 10 years" for as long as I have lived and each time it comes and goes and nothing is there.
  
  Granted, I'll credit there IS a big push for the CNTF, but we need to wait for the results to see how it goes. The results are mixed from those who are on the RPList that are participants of the trial. So it's hard to say which way this will really go. It may mean further study to find otu which types of RP this works for and which does not.
  
  Darran

• CNTF
• Posted: 2009-01-20 19:27:50 By Luis G
• Darran,
  
  Yes, we must be cautious and patient about the "promising" treatments. Definitely is necessary to wait for the CNTF results. I would not like to pay for something that could not work for me.
  
  Greetings,
  
  Luis

• Neurotech status
• Posted: 2009-01-15 12:59:06 By Colleen P
• Hi,
  Just wanted to pass on that we were told by a dr. from UCLA at a recent Canadian FFB conference that the CNTF results will be out in spring of this year. Then if the results are favorable then it could be available to the general public within 6 mths. after. He said "some people in the room could have the implants by this time next year." The conference was held at the end of Nov. Anyway just passing on what we were told.
  Glad to see you are back posting Darren. Hope your family situation is improved. Colleen

• CNTF
• Posted: 2009-01-15 18:06:15 By Carolina S
• Luis I am a participant in the study and YES the results should be available this spring. Unfortunately the CNTF did not work for me however there will be other drugs available with the ECT
  carolina

• CNTF
• Posted: 2009-01-20 19:32:21 By Luis G
• I'm sorry to hear the ECT did not improve your sight. Did you experience any other side effect?
  
  What type of RP do you suffer? Mine is CRD.
  
  From past posts, I could realize all that people suffering CRD experienced any improvement, well that was my perception.
  
  Greetings,
  
  Luis

• Posted: 2009-01-24 20:22:08 By Maria P
• I was told by my retina specialist who is one of those participating in the CNTF that this phase was to prove whether it's an effective method of delivery. Given that there were different dosages administered, it should be interesting to see if that had anything to do the side effects and/or vision improvement of the participants.
  
  Marisa

• CNTF
• Posted: 2009-02-06 21:48:46 By Luis G
• Hola Marisa:
  
  Qué gusto saber que todavía andas por aquí.
  
  Let's hope results are available soon, and these ones represent a reliable treatment for RP.
  
  Saludos,
  
  Luis