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 Darp101 [@DarpResearch](/creator/twitter/DarpResearch) on x XXX followers
Created: 2025-07-16 18:18:51 UTC
So what is the very best thing that can happen in regard to NVG-291 and patients?
Yesterday I talked with two medical people that have read what is available on the NVG-291 drug trial by $NGENF NervGen. They agreed on key aspects that I have been trying to nail down.
Both had the same explanation of why there was X outlier that, in the placebo group, had very good leg improvement. Both said it was NOT due to a new electrical connection. That the patient had apparently never been properly rehabbed with physical therapy before the drug trial, and that the improvement was from the therapy. One said it was likely that the person also sandbagged, that they had more capability than they let on about, so they would be able to get into the trial so they could get the drug. That such things do happen in trials. One doctor said the NervGen trial setup was superb in its design in terms of getting useful data.
So on to the title question, what is the best thing? With the additional info I got, an accelerated approval seems to be the case. It may be Fall before the FDA calls them in, but if it is fast-tracked at that point, in another 9-12 months it is feasible for the drug to be on the market. For the SCI community, fantastic. It will be expensive but available quickly if that is the case. As fantastic as that is, there may be even a bigger benefit than that. This is how. If a drug is given accelerated approval and is on the market, it can be used off-label by doctors. So people with MS, Alzheimer's, Stroke, etc. will be able to get NVG-291. And since there is human translation proven already and the mechanism for all of these indications is similar, JMHO, it is over XX% likely it would work for these other indications.
Now for SCI folks, it is expected that insurance will pay for NVG-291. It likely will not be instantaneous, but it does fit the criteria to be covered, plus SCI causes big expenses in the long term for insurance companies, so they have a motive to pay for it. For MS and Alzheimer's, insurance will not pay for it (as off-label), so only fairly well-to-do folks would get it for that. However, that then provides data at no cost to NervGen, in fact, at a profit for NervGen. If you have XXX people with MS, and the same with ALZ on NVG-291 there will be huge data available on its effectiveness. If it works, Big Pharma will be pounding on NervGen's door to partner on those indications. One doctor told me that people will go "doctor shopping" for off-label use and they would be able to find a doctor to prescribe it to them.
I did not know just how fast it could be available, especially off-label. Unfortunately, without accelerated approval, it will be much longer for patients and much more expensive for NervGen. Looking at the bright side, let's say it is accelerated.
NervGen would need money to crank up production, but that is not a huge cost compared to going through Phase X on multiple indications and then manufacturing. It is tiny in comparison. If, and I pray this does get accelerated, in potentially XX months NVG-291 will be on the market. Then NervGen will be highly profitable and IMHO quickly. That means they will have to raise way less money and will then generate money to do trials on the other diseases; they will be able to self-fund or partner on other indications.
The potential of many of the worst diseases being curable, or partially curable, in a little more than a year is mind-boggling in a good way. So whoever reads this that has some way to assist in accelerated approval, please do help. Cheers
XXXXX engagements
**Related Topics**
[$ngenf](/topic/$ngenf)
[Post Link](https://x.com/DarpResearch/status/1945548701919056172)
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Darp101 @DarpResearch on x XXX followers
Created: 2025-07-16 18:18:51 UTC
So what is the very best thing that can happen in regard to NVG-291 and patients? Yesterday I talked with two medical people that have read what is available on the NVG-291 drug trial by $NGENF NervGen. They agreed on key aspects that I have been trying to nail down. Both had the same explanation of why there was X outlier that, in the placebo group, had very good leg improvement. Both said it was NOT due to a new electrical connection. That the patient had apparently never been properly rehabbed with physical therapy before the drug trial, and that the improvement was from the therapy. One said it was likely that the person also sandbagged, that they had more capability than they let on about, so they would be able to get into the trial so they could get the drug. That such things do happen in trials. One doctor said the NervGen trial setup was superb in its design in terms of getting useful data.
So on to the title question, what is the best thing? With the additional info I got, an accelerated approval seems to be the case. It may be Fall before the FDA calls them in, but if it is fast-tracked at that point, in another 9-12 months it is feasible for the drug to be on the market. For the SCI community, fantastic. It will be expensive but available quickly if that is the case. As fantastic as that is, there may be even a bigger benefit than that. This is how. If a drug is given accelerated approval and is on the market, it can be used off-label by doctors. So people with MS, Alzheimer's, Stroke, etc. will be able to get NVG-291. And since there is human translation proven already and the mechanism for all of these indications is similar, JMHO, it is over XX% likely it would work for these other indications.
Now for SCI folks, it is expected that insurance will pay for NVG-291. It likely will not be instantaneous, but it does fit the criteria to be covered, plus SCI causes big expenses in the long term for insurance companies, so they have a motive to pay for it. For MS and Alzheimer's, insurance will not pay for it (as off-label), so only fairly well-to-do folks would get it for that. However, that then provides data at no cost to NervGen, in fact, at a profit for NervGen. If you have XXX people with MS, and the same with ALZ on NVG-291 there will be huge data available on its effectiveness. If it works, Big Pharma will be pounding on NervGen's door to partner on those indications. One doctor told me that people will go "doctor shopping" for off-label use and they would be able to find a doctor to prescribe it to them.
I did not know just how fast it could be available, especially off-label. Unfortunately, without accelerated approval, it will be much longer for patients and much more expensive for NervGen. Looking at the bright side, let's say it is accelerated. NervGen would need money to crank up production, but that is not a huge cost compared to going through Phase X on multiple indications and then manufacturing. It is tiny in comparison. If, and I pray this does get accelerated, in potentially XX months NVG-291 will be on the market. Then NervGen will be highly profitable and IMHO quickly. That means they will have to raise way less money and will then generate money to do trials on the other diseases; they will be able to self-fund or partner on other indications.
The potential of many of the worst diseases being curable, or partially curable, in a little more than a year is mind-boggling in a good way. So whoever reads this that has some way to assist in accelerated approval, please do help. Cheers
XXXXX engagements
Related Topics $ngenf