This video discusses the results of NervGen's NVG291 drug trial for spinal cord injury. The hosts, Jay Taylor and Chen Lin, analyze the market's reaction to the results, which were initially met with disappointment despite showing statistically significant connectivity between the brain and hands of participants.
The NervGen trial showed statistically significant connectivity between the brain and hands of spinal cord injury patients who received NVG291. This was established beyond a reasonable doubt, with the study physically detecting electrical signals from the brain to the hand, a first in human history. The management stated they had reached their primary endpoint of connectivity.
The market reacted negatively due to several factors: unrealistic expectations of complete walking ability (the ability to walk was the "talk of the town"), the small sample size (10 participants per group) making the data appear less conclusive, and the fact that one person in the placebo group also showed improvement, clouding the results and making them appear less clean and clear.
Following the initial trial, NervGen plans to file for accelerated approval from the FDA. Their strategy involves focusing initially on the hand functionality, given the clear and statistically significant positive results. They will discuss a pathway to approval with the FDA.
The video estimates the cost of keeping a spinal cord injury patient alive at $500,000 to $1 million per year. This high cost, coupled with the large number of individuals affected by spinal cord injuries, indicates a substantial market potential for a successful treatment like NVG291. The video also mentions the significant non-quantifiable emotional costs for patients and their families.
Beyond the core trial results, the discussion included:
The role of Dr. Jerry Silver: The inventors's passing was noted, and his previous research (focusing on the front limbs of mice) was discussed in relation to the trial's focus on hand functionality.
The leg's slower response: A theory was presented suggesting that the leg's longer distance from the brain might require a longer treatment duration or a higher dose to achieve similar connectivity results.
Bladder function: The trial's data on bladder function was mentioned, as improvement in this area is crucial for quality of life for spinal cord injury patients. Further data on this is expected.
Patients' self-treatment: The hosts discussed the concerning issue of patients seeking treatment by synthesizing the peptide in China and self-injecting it due to desperation for a cure, highlighting the urgency for FDA approval.
Market sentiment and short-selling: The discussion touched upon the negative market sentiment towards biotech companies in general, with a comparison to the mining industry's downturn, and how short-selling is influencing the stock price. The potential for a short squeeze upon FDA approval was also mentioned.
The potential for wider applications: The successful proof of concept in this trial opens doors to exploring NVG291's potential applications in treating other neurological conditions, such as stroke, Parkinson's, MS, and Alzheimer's.
