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I think you're right, Anton. Schneider only has a couple weeks to close, and I'm not that confident it will happen. That is completely fine with me. It sounds like Nemus went for more than they really needed so they could reverse split and uplist. I don't like the OTC either, but they should focus on the pipeline. They need to just raise a few million and get things going.
Let us know if you find anything out, first hand. I've heard they aren't good at answering important questions (nothing material, of course) - at least by email. I'd love to attend a conference or presentation, as you know I have a number of questions.
If it falls through I'm sure they have a contingency. They were smart enough to promptly exercise the guaranty. Schneider has been wasting a lot of time.
I took a quick look and didn't see anything either, so I guess they were paid. Atypical, but doesn't surprise me.
What costs? Advisers usually are paid in equity that vests, not cash.
NB1222 isn't technically the lead candidate.
Robert Weinreb was removed from Nemus' site sometime between July 2016 and February 2017. Judy Gordon was also removed from Nemus' site in February/March 2017.
JUDY GORDON, D.V.M.
SCIENTIFIC ADVISOR OPHTHALMOLOGY REGULATORY SPECIALIST
Pre-eminent regulatory specialist with internationally recognized expertise in regulatory filings at FDA/EMA for NCE’s for use in the ophthalmology space.
from her own company ClinReg Consulting Services' website:
"Judy F. Gordon, DVM, founder and president of ClinReg Consulting Services, has over 20 years progressive clinical, regulatory, quality and R&D experience in the pharmaceutical and medical device industry. She has worked to gain FDA approval for multiple PMAs for Class III devices, and has made many presentations to Advisory Committees. She has also directed clinical trials of biologics, pharmaceuticals, and Class I, II and III medical devices, from protocol development through clinical reporting to FDA.
Furthermore, Dr. Gordon has served as the industry representative to Medical Devices Dispute Resolution Advisory Panel to FDA and the Ophthalmic Devices Advisory Panel to FDA."
Those are questions only Nemus could answer.
$5 is unrealistic, but I would love to be proved wrong.
$20mm isn't that much. G&A costs are $2mm ytd, and those will increase as they move forward. Filing an NDA is around $2mm as well. It won't be enough to approve NB1222, enough to get started on two indications though.
"How can you say that there is no data showing the improved pharmacokinetics of the THC-VHS prodrug (NB1222)?
http://www.sciencedirect.com/science/article/pii/009130579390194X
http://europepmc.org/abstract/med/8897084 "
Those links are 20+ years old. Where on their website?
So the current patent is already ~9 years old?
"I'm not sure what the formulation would be with a transmucosal patch. I guess it would depend on what indication it is. But seems like down the list of things considering NB1222 (suppository) and NB1111 (eye drops-->contact lense) "
They've already said the transmucosal patch would be for CINV/CIPN. For those indications, a transmucosal patch is really all I care about.
"'wouldn't the absorption as a suppository be too quick?' No, see the above research. I think NMUS is in the proccess of answering your question. NMUS will prove it on the field anyway. You can say whatever you want, but the scoreboard doesn't lie."
I said if they used the prodrug that Elsohly developed for the transmucosal patch, which could be THC-VHS. If Elsohly said the previous prodrug's (from the suppository) absorption was too slow in a buccal patch, then it's perfectly reasonable to question whether the buccal compound would be too quick if used in a suppository. If it's a different prodrug altogether then that means a lot more time and money.
Nemus can prove it now, they would have already conducted in vivo studies. So why haven't they?
Generally true, though NB1222 will still be expensive even using the 505b2 pathway. $20mm won't go that far, and there are also g&a/research costs. The earlier they license the less it will cost Nemus, the tradeoff is a lower royalty. My concerns are efficacy and marketability. We know Elsohly developed a prodrug suppository years ago that was never successfully licensed. That patent expired, and we still don't know the pharmacokinetics of the THC-VHS prodrug, it may or may not be better. Elsohly mentioned that the transmucosal patch he developed (to treat glaucoma as well as cinv) initially used the suppository prodrug, but the absorption was too slow so it had to be reformulated. Will the transmucosal patch use THC-VHS? If so, wouldn't the absorption as a suppository be too quick? There are questions Nemus needs to address.
NB1222 won't add value if they can't find a partner, which is why dilution is important to consider.
Thanks, Anton.
You're right, biotech is a capital intensive industry which is one reason many don't make it. Unfortunately Nemus' efforts to attain non-dilutive finacing through partnerships hasn't been successful.
I've debated this stock ad nauseum.
GLTA.
I said basic shares, which right now is around 33.5mm. Series D would add nearly 67mm shares.
My point was that the long term downtrend is important - it's not a result of low liquidity, and as a consequence the dilution is significant.
Unfortunately the stock has basically been bearish since the beginning. Liquidity is a problem, but the downward pressure can't be ignored. It has lead to a relatively large financing that will triple the number of basic shares.
Correct, they may have a contingency but it wouldn't make sense to raise now when they've exercised the guaranty.
You didn't per se, but you said "you already know the compounds are efficacious". My point was that cannabinoids aren't going to be effective for every indication, even if the research was validated in an animal model. For example, Sativex failed their cancer pain trial in phase 3, and right now it doesn't look like CBD is effective in treating focal seizures. I wasn't surprised that their trial failed, and you shouldn't be either.
From what I understand, GW is lobbying to have CBD reclassified as a schedule IV drug. In the SD bill, I believe the 'FDA approved only' wording was ultimately removed. I'm not sure about what's happened/happening in other states.
There is an established safety profile, but cannabinoids aren't a cure all.
Perhaps the problem is with their permeation enhanced gel. I haven't followed them too closely, but iirc top line data for other indications should be released in the near future.
Not unusual, on average only ~33% of drugs pass phase 2. Even if their research was sound, just because something works in an animal model doesn't mean it will work in a human.
In their 2016 10-K, it mentions that there is a US patent regarding the treatment of partial seizures with 400mg+ of CBD.
I assume they are referring to this patent from GW.
https://www.google.com/patents/EP2448637A1
Doesn't seem to matter now that the trial for that indication failed. Good reminder about intellectual property protection though.
What patent issues?
Unfortunate, but reiterates the importance of risk assessment.
Just to be clear, I agree synthetic is the way for to go, which is what Inmed, Zynerba, etc. are also doing. I'm not sure how much of a market share a cannabinoid based antiemetic could capture if it's considered last line, which is why I was curious about vinpat's valuation. Perhaps their buccal patch will change that, when ready.
It will also be interesting to see the efficacy of the current prodrug against a THC suppository. Do you remember seeing a comparison for a previous formulation?
Inferior regarding quality or safety.
I've already explained why it could theoreticaly be a consideration.
I never suggested smoking/edibles were superior.
What study did you reference? No matter, I mentioned IV only because I said transmucosal and transdermal are the most effective methods of delivery, other than IV which would have a 100% bioavailability.
CB1 receptors develop a tolerance to THC fairly quickly, which could affect IOP reduction. It's simply a concern, this is why it's important to account for risk when valuing a drug. We've discussed this - you (I'm paraphrasing) suggested Elsohly et al will figure it out, I thought that was strange and then went to Europe for a few weeks.
I simply asked vinpat whether or not he performed a valuation. If he did I'd be interested in knowing which valuation method and variables he used.
Plant derived drugs aren't uncommon or inferior. The advantage with biosynthesis is mainly reduced time and cost. There could be indications where the whole plant may be superior to THC alone, perhaps where CBD could moderate the psychoactive effect of THC, if the dose were high enough. Other cannabinoids could have a synergistic effect as well, possibly even terpenes though it would take years to study. Some researchers are skeptical of the entourage effect, it would be interesting to study dronabinol against a bioequivalent edible rather than inhaling cannabis (if it hasn't already been done).
The delivery method is critical, transmucosal/transdermal are unquestionably the most effective, other than intravenous. A topical preparation would of course be most effective for glaucoma (though I'm skeptical that NB1111 will be successful because of tolerance).
"But if it's valued at a couple hundred million $$ then that's not bad for a few years work...".
Not bad at all, is that just a hypothetical figure or what you actually think it could be worth to Nemus?
That's data for Medicare, so the number is higher. However, a significant number of dronabinol prescriptions are for appetite stimulation.
I've read that Cesamet claimed to have ~90% market share in Canada as well.
I'm sure it's more than $50mm, but the market for a suppository formulation wouldn't be as large, and if they in-license the royalty will be low.
NB1222 is a prodrug, so it will likely need a phase 3 trial (source: your link). Phase 3 trials are never small. Approval will still take several years, and dronabinol/nabilone (for CINV) are only approved as last line treatment options meaning they are only prescribed when patients fail to respond to conventional antiemetics. NMUS needs to license NB1222 (or in-license unfortunately), and that doesn't require an NDA.
I didn't know until I read your link that 505b2 pre-ind meetings occurred before formulation development. I don't remember NMUS mentioning that they had completed a pre-ind, but I guess they did. Seems like something that would be in a presentation or part of a pr.
Anyone else notice NMUS mistakenly referred to NB2111 as NB2222 in their last pr?
Only a bit surprised that people would buy now at the same price or even higher than when the deal was on track. The sp has fallen below financing prices before, that's what led nmus to adjust the conversion on series b and c to $.25 and iirc, the warrants as well.
I don't know what's going on with Schneider. I suppose the SunGame deal should have been somewhat of a red flag. I find it a bit hard to believe they would need an extension for a deal they sought 2-3 months ago, given their assets. Nemus has good lawyers, but litigation would be costly and time consuming. I'm surprised the sp has held with the deal being in question.
Can't really compare NMUS to an LP though. I'm sure they can find a couple million in short order, but they need enough to start advancing the pipeline.
So your answer is "don't worry, Elsohly will figure it out". Seriously?
...not sure what you're talking about.
Not the eye per se, but since chronic use of cannabis down regulates CB1 receptor activity, especially in the brain, I was wondering about the eye. The potential for tolerance had been mentioned in a few studies regarding glaucoma, but I didn't find much beyond that. I read a very small study where nine patients either inhaled cannabis or were administered oral THC, and although IOP was initially decreased it was not sustained. Nothing definitive, there's probably another study that had a positive outcome, but it warrants further research.
Other than the fact that UM is presenting at ICRS, it doesn't seem like there's anything new. UM already presented their normotensive research at AAPS in November, so we already knew NB1111 was effective and safe. I'm sure they have some additional data, but it sounds like it's relevant to the research community and not investors. I wonder if they've tested NB1111 for a more significant length of time (not just 5 days), it would be interesting to know if the cannabinoid receptors in the eye develop a tolerance to THC. Seems like something they should have done already. Anybody know?
The transaction probably isn't completed - If I had to hand over $20mm I would do it as late as possible (opportunity cost). NMUS has been downtrending since inception, there's nothing to suggest the deal will fall through. If that were the case then I would agree with your $.15 target.
I'm interested in seeing how this plays out. Time will tell.
I'm aware of the fact that a suppository has greater bioavailability and that the liver converts delta-9-thc to 11-hydroxy-thc. I was referring to Dr. Russo's opinion that 'THC alone is a lousy drug'. Regarding side effects from ingestion, I'm not sure that is of much concern with dronabinol or nabilone.
The article was about synthetic cannabinoids. I read an article where Dr. Ethan Russo (neurologist, psychopharmacology researcher, former Senior Medical Advisor to GW) talked about dronabinol:
"THC-only pills have been available by prescription in the U.S. since the 1980s under the brand name Marinol, which is synthetically produced THC dissolved in sesame seed oil. Russo says people often discontinue Marinol due to negative side effects, which he believes come partly from the absence of marijuana’s other cannabinoids. “They get anxious, dysphoric [and] scattered,” he says. “It interferes with their ability to function.” The U.S. Food and Drug Administration in 2016 approved another oral THC formulation called Syndros: pure, synthetically produced THC dissolved in alcohol... “THC alone is a lousy drug. It is a very poor therapeutic index,” Russo says. “I’ll tell you right now, [Syndros] won’t be exciting or gain a lot of traction either.”"
Would a suppository be any different? Nemus also didn't mention that for CINV dronabinol/nabilone are approved as last line treatment options meaning they are only prescribed when patients don't respond to conventional antiemetics.