timberwolf7
4月前
This is the problem with the clinical trial process.
IF they are showing signs of success, IF there are
side effects, but 'minor' like shot site flaring up.
Why now allow them to do a 'phase 4' type of trial vs
running a PH 3. They could start 'treating' folks who are
willing to 'try' and record the observations as 'clinical' data
(redefine what and how its collected for each one trying it.
Won't be perfect, but if someone can't walk 10 meters, and then
can, who cares how long it took him for example.
Or couldn't open their hand for years, but now can? Who cares
how far he can, if he can flatten his palm, et al
I was kind of wondering if the fdA might work with them to speed up
the potential approva IF visible results are being seen.
But alas, this is the current timeline which of course likely means the
current share count of 80 Mil goes up (ATM) due to a need for funding
in order to survive till the trial is over in the 1st half of 2028. This is just
too long for something they are already seeing results that can't be
challenged.
Prepare for Pivotal Phase 3 Study Initiation: Expected Mid-2026
• Expected Completion of Enrollment in 2H 2027 with Topline Data in 1H 2028
Disclaimer: been a long time since i owned any, dilution and getting in way too early
aren't a winning combination. And hate it when the Market Cap gets run up this early..
timberwolf7
5月前
Have tracked NGEN(f) for a few years now. In their investor
deck is several 'testimonials' from clinical trial participants.
An end of PH 2 meeting with the fda 1st half of 2026.
Been telling myself, IF this showed effectiveness? Minimal
side effects by the end of the PH 2?
What would the odds be for something with the potential to seriously
impact folks lives in a very good way, not needing a full PH 3, maybe
even not needing a PH 3 to get approved. And running a PH 3 as a
confirmation data gathering effort post approval instead of denying this
potential treatment for another likely 1 1/2 to 2 years to do a PH 3??
disclaimer: don't own any. Concern over a couple of aspects:
Market cap already sitting at $430 Mil based on around 80 Mil
shares. $11 Mil or so in cash on hand (will they need more dilution?)
Chance for a buyout??
To close, like what I am seeing, but what is the fda giong to say in response
to the results. Cause having to develop and run a PH 3... Good luck..
Grey_Ghost
1年前
NervGen Pharma to Present Topline Data for NVG-291 Phase 1b/2a Chronic Cohort Study at the American Spinal Injury Association Annual Scientific Meeting
VANCOUVER, Canada, May 21, 2025 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuroreparative therapeutics, today announced that topline results from the chronic cohort of the ongoing Phase 1b/2a study of NVG-291 will be presented as an oral presentation at the 52nd American Spinal Injury Association Annual Scientific Meeting being held June 2-4, 2025 in Scottsdale, AZ.
“We are looking forward to completing the data analysis, unblinding the data, and presenting the first results from the chronic cohort in this initial proof-of-concept, double-blind, placebo-controlled clinical trial of NVG-291 in spinal cord injury (“SCI”),” stated Daniel Mikol, MD, Ph.D., NervGen’s Chief Medical Officer. “In this trial we have incorporated both clinical assessments as well as electrophysiological assessments of connectivity, as we feel this gives the highest probability of observing and characterizing an efficacy signal with NVG-291. We are hopeful that the results of the chronic cohort of our Phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable neural repair in individuals with SCI and will support further investigation of NVG-291 in SCI.”
https://nervgen.com/nervgen-pharma-to-present-topline-data-for-nvg-291-phase-1b-2a-chronic-cohort-study-at-the-american-spinal-injury-association-annual-scientific-meeting/
timberwolf7
2年前
Q3 was their 'goal' for enrollment in the PH 1/2A study..
IF they say they saw improvement in motor skills (ie, its working)??
Guessing the fda will require a PH 3 of some sort, even if this does help people
and shows no safety issue (another one ATNM has something that works, but the fda
is making them do a new PH 3 trial, that denys people that could benefit from their
development from helping save/make their lives better)
So guessing even if this shows it works, can help folks get better, the fda will
force them to do a PH 3 which means a few more years.. Damn..
tootalljones
2年前
Lin's comments in the Taylor interview just posted are big. He is saying, that he knows of a patients, via his mother, who son has gained significant, meaningful mobility. In fact, substantial mobility. He is also saying there is scuttlebutt and buzz around the patient group taking 291 -- their families and friends, which if you listen to it, means the drug is working. Working quite meaningfully. As he remarks, the patients themselves cannot say stuff, but they can share how they are doing with friends and family. And the F and F themselves are under no contract or agreement Not to communicate about the progress, if any. And the F and F's are themselves talking about real progress. SuBstantial progress, and this is why Lin is saying this is a trillion dollar opportunity.
tootalljones
2年前
Jay Taylor and Super Investor Chen Lin start about Nervgen at the 13.40 minute mark. And Lin is following his old Sarpeta Model where he bought that stock in the low single digits. He himself related years ago, that he actually flew to the home of the first patient treated, who could not walk, and saw with his own two eyes, that after receiving the SRPT drug, the young patient could walk. Chen related in a Jay Taylotr podcast, "What could I say. I saw him, and he could walk!" Lin perhpas made 50X his original investment, and SRPT stock today is 150 bucks a share.
And if you listen to him carefully, you see that he is pretty much following the same formula with Nervgen, which he sounds far more excited about, calling it a 'TRILLION DOLLAR OPPORTUNITY"