Yet another delay

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I think I'd prefer it to be done right the first time rather have them say OOOPS 3 months down the road.

It sounds to me like it's probably business as usual. I'm sure this happens with meds for all conditions ... that's what oversight is for. If they don't meet government standards every step of the way, they won't get approval at the end.
Yeah, I think Beth is all over it-I think this kind of thing is pretty "normal" for research. Al-you got it too, I'd prefer no OOPS:)
yes I agree, get it right first, then we will all have something to celebrate....this treatment is getting tantalisingly close
i really do hope 2009 is the year for pals. i'm rooting for medical science.

god bless.
the FDA may choose to "fast track" this research once their questions are answered. fast track shortens the normal time from IND to market time period. the average time from IND to market is 5-7 years. fast track reduces or eliminates some of the requirements during the 3 phases of clinical trials. it could still take 2-3 years if everything shows clinically relevant results, but i'm not that optimistic.

stem cell research has more unanswered questions than answered. it is cutting edge science and i'm sure it holds great promise. don't get me wrong, i want a medical breakthrough/cure as much as anyone with ALS. i am more worried that i may have passed this to my kids and i am confident that a cure/treatment for ALS will be found before they get in the age bracket for typical affliction.
Other types of potential treatments

You may be right on the time frame for stem cell treatments to reach the general ALS public, jimmybob, but remember that there are other types of treatments they are looking at besides stem cells, such as new drugs and gene therapies. So let's keep up the hope!
Amen Big Mike!

Never give up,
Never let up,
Never lose faith!
Not to beat a dead horse

Not to beat a dead horse, but this is a very normal part of the FDA approval process. I think it is still very likely that Neuralstem could get approval in the next 6 months or so. Sure will be nice to at least have something promising in the of now I dont know of any "trials" or mouse studies worth watching!

You're here: CEO Blog Home A hold by any other name…
Posted by: prosperoOn: 02/20/2009 10:46:43In: CEO Blog
For those of you who are unaware, the Company received it’s written response from the FDA, to our application to begin a clinical trial to treat ALS.

The trial is on what is called a clinical hold, until we provide the FDA with satisfactory answers to the written questions it has asked, and agree to make to the changes it has requested to our protocol. Or in the alternative, get them to change their mind and agree to our original protocol. We are somewhat restricted in what we can say about their specific comments, but in a press release today we characterized the questions and requests for information regarding the manufacture of the cells and our pre clinical data as reasonable, and all answers that the Company could provide quickly. We characterized the recommendations for changes to our protocol and to the inclusion criteria for patients to qualify for the trial, as things we are reviewing and need to think about before responding. Finally, we stated that overall we thought the comments were helpful and that we were confident that we would be able to come to an agreement with the Agency on all issues to get the trial approved and move forward.

For those of you who have heard me speak, you know that there is nothing unexpected in this FDA response. We have said all along that because what we are doing is new, and because everything involved in the trial from the cells to the surgery itself is novel, that we expected to be put on hold and answer various questions for the Agency before they would approve the trial. I also have said, based on that expectation, that we still hoped to start the trial this spring. I still believe that that is the case. Although we are getting these comments about a month later than we had hoped, so perhaps by this summer is more realistic than spring. It is impossible to tell of course, but that would be my guess. There is nothing in the response that seems outside of the response we expected, and no questions asked for which we feel we do not have the correct answer. Still, it is a process, and we are not necessarily in control of the calendar, hence the uncertainty. What I can add however, is that to date the Agency has been extremely helpful, straightforward and diligent in all of our interactions with them, and I would not expect that to change.

I have had the privilege of meeting many of you over the past two years, and I know first hand that the ALS patient and support communities are truly inspirational. Some of you know that I got involved in starting Neuralstem because my young son had a brain tumor, so I can promise you that everyone at Neuralstem understands the crushing urgency of “now” to your community. I will repeat, we see nothing in this response that we did not expect to see, and in no way view this as a set back. We feel very positive about moving forward. Yet we know that to you, there is little to celebrate in a step in a process moving inexorably, but only steadily forward. We know that a hold, by any other name, is still a delay.

And so I will end this blog the way I have ended all of my emails to those many patients and family members and friends of patients who have written me and shared their stories, and their hopes. We are confident in our science, and we are working as hard and as fast as we can to be able to bring it to you.
I have been reading lots and lots on new treatments for this disease, and I can honestly say I'm hopefull that great treatments are on the horizon - I wouldn't be surprised if in 5 years there is a cure! and this isn't even wishful thinking!
re: few clinical trials worth hoping for going on now

Although I am not too sold on some of the clinical drug trials underway right now, such as the Cefriaxone and the Telampanel drugs, there are a few that could be promising that are in stage 1 or 2. A couple of these, such as sNN0029 and SB-509 drugs contain the neurotrophic factor, VEGF, that could be beneficial to slowing the progression of the disease. The drugs KNS-760704 and TRO19622 could also prove to be beneficial for PALS.

The folks at the ALS Therapy Deveopment Institute are also working on developing gene therapy treatments. And of course, there are the Neuralstem stem cells trials, the first of which should start later this year from what it sounds like.

So hope is alive!

I don't mean to be ignorant but what does IND stand for?
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