Introduction to NervGen and NVG-291 (Video)

[Boone 870]

Yes, if they get the FDA "breakthrough" designation it will allow them to enter the market after showing some efficacy. This is because the breakthrough designation is for conditions where there are little to no publicly available treatments for. The goal is to encourage some treatment to become available by lowering regulatory thresholds.

I have no doubt that if they can show even a small amount of efficacy they will get the designation.

Dr. Silver had mentioned in a previous video that he was very confident the drug would receive "breakthrough" status with the FDA. If I remember correctly, someone said in one of the videos that the stage III trials would start at the beginning of next year and they would know the results within a year. NVG-291 could reasonably be expected to be available within three years, that's very encouraging.

[Mitchitsu]

Yes, if they get the FDA "breakthrough" designation it will allow them to enter the market after showing some efficacy. This is because the breakthrough designation is for conditions where there are little to no publicly available treatments for. The goal is to encourage some treatment to become available by lowering regulatory thresholds.

I have no doubt that if they can show even a small amount of efficacy they will get the designation.

I respectfully disagree with your last paragraph. Most people with SCI are in relatively stable condition.

We are not talking about people at risk of death if not treated. We are not talking about people who will become progressively worse if not treated.

The breakthrough designation might be an option, but in my humble opinion, they would need to show much more than a small amount of efficacy. We are not talking about a progressive cancer that existing drugs are not working for.

Although I really hope I am wrong about this and you are 100% correct.

[bam23]

With the number of time they said that they are confident to get the breakthrough designation and that it only need to show a small percentage of what they saw in the pre clinical study, i would really be surprised if their statement are not based on something. I mean they already are in contact with the FDA.

And i found this on the FDA site:
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.

should be easy to show an advantage since there is no therapy available

[ineedmyelin]

From unite2fightparalysis 2022, go to 40 minute mark
https://www.youtube.com/watch?v=Gi0DGf288Fk

[lunasicc42]

a boost for nervgens Spinal cord injury trials

A boost for NervGen's spinal cord injury trials (healtheuropa.com)

[ncs91]

Kumbaya Jerry, kumbaya!!!...