Dr. Johe is down in Miami in his virtual office - Neuralstem appears only to claims employees in CA and MD. The DOD program went nowhere, and it is likely that the Canadians forged the seminal patents he now claims. Garr made sure that to sidestep the issue. The immunotherapy protocol used in the CUR trial is not even described in clinicaltrialsgov. After the 1a, and Ted's response, at the very least, they should have run their control in the 1b trial. In my opinion, the should have then enrolled the 120 patients on the immunotherapy regimen alone - results would be available quickly. I tilt this way because Ted's response was rapid, within weeks of surgery -- stem cells don't appear to work that quickly. Patients would have been spared the highly invasive surgery, for a more certain approach. Eva is not a site in Glass' trial, which is strange, because she has altered her description of the 1a conclusions to include potential "salutary" effects of the novel immune regimen. Her overseas vacation tour of the results from the 1a are a bit bizarre; I'm sure she had a good time. And, the radio tour with Ted and pictures and press in the operating theatre are a bit troubling. Maybe they've watched too much reality TV -- in science you wait until you have proof. Speaking of proof, there is no human data published on NSI 189, and contacting NFL players smacks as a huge publicity stuff - the stuff of carnival barkers. This could get strange quickly, or perhaps Garr will win the lottery. He just gave himself a boatload of insider shares, in his revisionist history of the annual shareholders meeting. Regarding the DOD, at the time their free money from Clinton ended, they had made no impact on clinical medicine, and the Canadian researchers had published and patented their claims on neuron stem cell culture and propagation in both wet and dry media.
LOL. The facts:
1. NSI 189, figment of Johe's imagination? - No, it appears to work in rodents. Most agents that work in rodent's don't work in humans, but I'm thankful there are smarter mice out there!
2. Ted walking may have everything to do with his novel immunotherapy regimen (including Cellcept). He experienced a response at 2-weeks, too early for stem cells, this led Glass to hypothesize, and many of his colleagues that immunotherapy was responsible for Ted's response. Those are his words, on clinicaltrialsgov, so he started a trial, and MGH is working with him. They so far have refused CUR's overtures. What Garr doesn't publicize is Ted's setbacks. You can read about these in the press.
3. The ATM would be a piggybank for executives if GARR already knows that NSI - 189 showed no efficacy signal - I believe this is the case - but you never know. More concerning is the 7 million in free shares that Garr claimed had not been granted by at the annual shareholders meeting, and then mysteriously showed up in a 10k as "an incorrect vote count." Shady, and the SEC will likely investigate.
4. Garr has claimed lots of partnerships, the phantom NFL deal with no terms, Mexico ALS partnership which was imminent 6 months ago, the MGH site for ALS - retracted.
Investors should be considered. I'm waving the red flag. However, NSI 189 results could very well show an efficacy signal and Garr could be deep in negotiations. However, based on his track record, you'd have to rate that probability as low. But, you have to be in it to win it. ;)
CUR predicted and retracted MGH as a study site several times - then MGH signed on quickly to the Glass novel immunotherapy trial. Does Glass know something that Garr doesn't want you to know?
Check out how much Guidance Garr has missed. And, where is that fall ALS P1 publication? Did Eva adjust her conclusions too much, or perhaps that vacation, errr, overseas presentation tour was not well received.
Has Garr been obfuscating the NSI 189 data release timing? Does he already know the outcome? Will it be a Christmas Eve Press Release?
Material study results must be revealed after they are known -- large companies might successfully argue that a P1b trial is not material. For Neuralstem it is...From the timeframes Garr has spouted, he would know the results. This is an easy trial to conduct. It would appear he is sitting on results, which is never good. Positive results in the press would mean more interested partners. I keep doing the calculus, and I don't think there is an efficacy signal, and Garr won't tell anyone until we're on holiday. Who knows, maybe he can pull a rabbit out of the hat, but I doubt it.
1) Neuralstem is measuring efficacy with two depression instruments. At baseline, and at 8 -weeks - the time when SSRIs have shown stat sig results (curves separate, receptor attentuated). You can see the two assessement instruments listed in the investor presentations, one is MADRS and was administered remotely by I believe, MedAvante (there is only one other CRO who does this, but believe Maurizo is affiliated with this one). They left this information out of Clinicaltrialsgov, becasue if you want to milk your company - you never want to fail. You don't overtyly fail if you don't list an efficacy endpoint in P1, but continue to show safety
2) The mice grew their brains at 28 days. If you look at Eva's presentation she provides the rodent references.
3) 1A demonstrated the molecule was extremely safe.
4) What works in mice most of the time doesn't work in humans -- Garr has jumped the gun sputtering speculation in PRs - the sign of an immature CEO. He likes to preach despite a complete lack of experience.
5) If they are not picking up a signal or trend, or showing the same with the hippocampal volume @ week 8, this drug is going nowhere. Garr has already telegraphed the desperate move of a P2 similar 90-day study. I don't think big pharma or anyone will license without an efficacy signal. Why would they? Any discussion are predicated on an efficacy signal. Remember Garr has a horrific record of closing deals - phantom NFL, ALS Mexico, MGH (which signed on with Glass in the immuno study instantly). He clearly doesn't know what he's doing. But anyone can get lucky.
6) Odds of 1B efficacy success in depression with novel compounds are less than 15 percent in MDD.
My guess is that NSI 189 has no efficacy signal, which would likely kill the program. Garr likes to play the game and issue negative releases on a Friday. For news this negative, I suspect it will be in the week between Christmas and New Year. The ALS publication that was supposed to occur in the fall has also not occurred, and there is no concrete evidence that Garr as any agreement with NFL Alumni - it smacks of a publicity stunt as 189 has no human efficacy data. The only thing he has been consistent at is missing his own guidance. The 7 million insider dilution is atrocious. If you think he cares about patients, it is only if it is in his interest - consider that the company does not even acknowledge Glass' immunotherapy trial, a direct offshoot of the CUR trial and proposed hypothesis why Ted experienced such a quick improvement - stem cells don't work that quick. Let's hope there is an efficacy signal for 189, and Garr has just fumbled guidance -- but don't hold your breath - he's already tried to moderate expectations in his infamous blog.
Eva - with her evolving phase 1 summary results - fails to mention Dr. Glass has start an immunotherapy trial with the novel regimen used in the CUR trial. Many neurologist feel this may be responsible for the rapid response Ted experienced.
Garr guided for data that never materialized (breathing data), and then indicated it would be published in the fall. It is now winter. Eva's vacation presentations, and radio tours with Ted are not the norm for medical research. Publication of trials not posted on the NIH clintrial site at inception are not eligible for publication - as was the P1 ALS trial. Will there be an exception for the ANA President?
What a hot mess of misguidance, or are they outright lies?
Police probe Novo Nordisk for late disclosure of drug setback
13 hours ago
* Danish FSA reports Novo to police over slow Tresiba report
COPENHAGEN, Dec 10 (Reuters) - Novo Nordisk, theworld's largest insulin maker, is facing a Danish police probeafter it was reported by the financial watchdog for notdisclosing at once that its big new product hope Tresiba hadbeen refused U.S. approval.
This is a sleeper - there is a high probability of efficacy for neuronal stem cells in this indication. We are likely to hear interim news. This is also the largest market for any stem cell population currently in human clinical trials. SCI is likely to be a slog.
Abracadabbra. Seven million shares for executive and employee compensation fail to pass on a vote at the annual shareholders meeting, and then a mysterious SEC filing, and WALLAH!, ummm, it was mistake, it really passed, despite what I personally said, and I don't have to explain it. And, I thought shareholders were the true company owners.
Make you wonder? Should make you worry? This man should not be running a biotech company? And then, the hype about NSI 189 despite ZERO evidence of efficacy in humans. Multiple delays in 1b data. Hmmm. Numerous guidance missed. Maybe a miracle will happen, but red flags abound.
Let's see if he dedicates another love song to an active trial patient.
Garr in Mexico for the holidays setting up his stem cell clinic? Cut rate prices? Vamanos! Or, maybe in China pre-identifying patients for his ischemic stroke trial that was imminent 9 months ago, at their wholly owned subsidiary with no offices - virtual as in non-existent? Maybe we should start the weekend bar hopping with a warm, fuzzy song. Please sing along with Garr:
"So excuse me forgetting, but these things I do
You see I've forgotten if they're green or they're blue
Anyway the thing is what I really mean
Yours are the sweetest eyes I've ever seen" - Elton John
What a dump today. CEO devotes love song to active trial patient. Now, I've seen it all - or maybe, not.