Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I think they are. OVRL is 4x normal volume already. I think OVRL is overbought compared to Spihf but it is what it is.
Thanks for posting the article. I see no mention of the likelihood of developing resistance to the Durata drug. Seems it would be mentioned if it was a salient feature in favor of this drug. B will be the better choice if it is of equal or better efficacy, for this reason alone. Also, keeping fingers crossed for the single dose of B, which I see from the article is next up for a trial with the Durata drug.
I have been wondering if the merger announcement will delay the uplist. While OVRL is on Nasdaq, it is a proposal that fundamentally would alter all information submitted on the application made by Sphere. The outcome of the merger is unknown at this time so might Nasdaq want to wait until the outcome is known? The merger would strengthen the case in my view but that doesn't mean Nasdaq wouldn't want to know the specifics of the company they are making a decision about. Perhaps someone going to the AGM could ask if there will be an impact.
Looks like OVRL is settling in at around a 15% discount. I decided to go that way today knowing full well the discount is associated with the risk of closure. The discount netted me about 490 extra shares of SPIHF on my trade assuming completion of the merger. Was just too big a possible incentive to pass up. Hey JB - figured into that was about 6 shares of Spihf that I will get if and when the merger closes because I didn't have to pay that stupid $50 fee to Fidelity as OVRL is a U.S. company. Can't believe Fidelity won't relent on that. It was an important part of my decision as I didn't want to take the title away from you for having paid the $50 the most times. LOL!
Whoops- From the clinical trial site:
"Subjects randomized to brilacidin will receive either a single intravenous infusion (0.6 mg/kg or 0.8 mg/kg) followed by six days of once daily placebo, or a three day regimen (0.6 mg/kg on Day 1 followed by 0.3 mg/kg on Days 2 and 3) followed by 4 days of once daily placebo. Subjects randomized to daptomycin will receive 7 days of treatment."
Very interesting. A little bit ago I was reading SE88's post about things primed and avoiding regret etc. I hemmed and hawed but decided to buy 3000 more. It went through 20 minutes before the halt. Now I wait with all of you to see if that was serendipity.
Here is the link to the award to U of Kentucky discussed earlier. No mention of whether we are subcontracted on this or if our bid was with someone else.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/ucm391336.htm
Here is my take. XXII created a new part of their company and named it Botanical Genetics, thus it is wholly owned by XXII. Botanical Genetics (using XXII money) is investing in an unknown plant biotech, first for 10% and then if milestones are met, another 15%. We (XXII)are Botanical Genetics.
Your info on who was going on Asian trip was spot on so no reason to doubt what you say here. Seems most likely they will sponsor research to be done at Universities etc. as in past with exclusive rights to the results.
ly2835219 is a study of the drug Fulvestrant, a synthetic estrogen receptor antagonist. It involves a few different types of solid tumor cancers. Dr. Shapiro is the lead investigator. Here is the link:
http://www.dana-farber.org/research/clinical-trials/clinical-trial.aspx?tid=2386
Edit: Shapiro is the site investigator at DF.
I guess yesterday's news to now is a long time to be drifting around in a news blackout for you. The warrant news was quite significant.
I don't flip between the two but what really interest me is your statement about leverage. I know what you mean but see it the exact opposite. With half the market cap I see each share I add to spiffy as having twice the leverage of xxii. Still, I own more of ciggy because Sabby made it impossible to resist back when. But all my recent adds are to spiffy. I do think the catalysts favor movement in ciggy short term.
No I don't. But it is pretty obvious that after ONVO announced its intention to up list it had (not has) more appeal to the general public. Look at xxii volumes after announcing intention to up list and the volumes noted in Jokinmike's post. It had more appeal is straight forward. But I am with you on potential. More here. ONVO was a fun play but I do not own it any more as the potential is out a ways. Made a few bucks there. Is it science fiction as you suggest? Time will tell.
You seem to have good info. Some confirmation of that today. I am now paying very close attention to your posts.
I was in ONVO during the up list. It was pretty exciting. It appealed to both the biotech and the 3D printing spaces and was getting play all over the investing landscape. The CEO was dependable (like Big Puff) and did exactly what he said he would do and when he said he would do it. Sometimes ahead of when he said he would do it. Can't emphasize enough how important that was to me as a shareholder and that ability to deliver is appropriately reflected in some of the content of this month's newsletter.
ONVO probably had more appeal than XXII to the average investor but there is no doubt that XXII is in much much better financial shape and its product line is closer to reality and less speculative.
Great job with the March issue Scott and Mike. Thank you.
I wonder how many more of these signs there will be before we get to Wall Drug?
If BAT were to do that with XXII IP they would have to elect to exercise the commercial license. I wonder how much they would pay XXII for the commercial license?
Generally I agree with you. When Van originally described xxii to his subs he said it had 50 to 100 bagger potential. We just need to keep the word potential in mind. No guarantees.
Yes, and Walmart would be a 9090 bagger per Lynch. That is 2272 homeruns and a double. Wow!
When I first read this I thought Van wrote " I expect that to change soon." I was re-reading post 2251 and this is what it actually says:
"2. Yes we are still very much under the radar...I expect to change that soon."
Very different connotation to that. Much more of an active role by VanGor. Wonder what he has in mind?
Call this an expression of skepticism about timely and forthright government action in dealing with an issue. I think the FDA is fine with, and likely secretly hoping for, a quality VLN product being in the marketplace right now and will not put any roadblock in the way of XXII moving forward and labeling a product as such. Production could start very soon with the MSA. I suspect the FDA actually is hoping for passive widespread adoption before they conclude their years of study that might drive them to actually have to decide to do something like mandate lower nicotine levels. Market driven acceptance makes their job easier by avoiding a backlash from tobacco companies and other parties that the FDA will likely confront with a ruling that is perceived as a radical departure from the status quo. Why not let XXII (and BAT through Reynolds) carry the ball and get things rolling for them as they are part of the industry and it is easier to let it evolve from within than be forced from outside the industry? With this in mind, I feel it will be quite awhile, if ever, before the FDA formally regulates nicotine content, but that will not be an impediment to the adoption of xxii technology, albeit in a more gradual fashion. In fact I could see at the conclusion of all the studies that the FDA might proclaim that their research program was a resounding success but no further action is necessary because the research supports what the marketplace has already decided and those wanting to try the VLN route have several options available to them that have been used by many people to quit smoking. Sound about right?
Good post 58. Might be that Leo is trying not to use all the Aspire funding as it is dilutive and there will be a need for even more trials in the future. That was my take as I think the burn rate is likely to accelerate. A BOD is a recurring expense, not a one-time expense like a trial. So I was thinking Leo wants to get further down the road with the one-time expenses before he takes on more overhead. I have always admired Leo's ability to keep a tight rein on expenses.
But you are absolutely correct - the maturing of this company requires a BOD that will meet the requirements for up listing and provide reassurance that accounting and conflict of interest issues are being addressed. I think the 10 Q indicates those issues are unlikely to be addressed in the immediate future. Should they be? A different question. Leo seems to be indicating that he wants to use the known resources a different way.
The fly in the ointment for me is that we will never be able to up list as things stand now. I want to see that and maybe it would provide enough momentum to make the financial issues moot. A partnership is likely the quickest way to resolve all of this.
Thanks BK.
Wow, a lot of interesting posts lately. This one will seem dull by comparison but at least it has a different focus for those that need a break from the other stuff.
I reviewed the 10Q and noted a couple things not mentioned by others:
1) I really liked BK's post 52417 providing a succinct and (to me) plausible timing scenario for the ABSSSI Brilacidin trial . We are all dealing with incomplete information but BK's timelines seemed quite doable and realistic as opposed to some other projections which had the trial over in a month because of the short dosing involved. The bottom line of his post is that he projected completion of the B trial near the end of 2014. Again , seemed quite reasonable to me and I kind of built that timeline into my way of looking at B. So I was surprised by this information from the 10Q:
"The FDA therefore supported the use of brilacidin in an upcoming U.S.-based phase 2b clinical trial comparing three short-course regimens (two single-dose regimens and one 3-day regimen) to an active comparator, daptomycin. Similar to the previous trial, the study is to enroll approximately 200 patients (50 patients per arm). This trial received IRB-approval in early January 2014 and is scheduled to begin enrollment in 1Q 2014, and to conclude enrollment by the end of 2014."
If this is the case then enrollment will not be wrapped up until the end of the year. Then comes the rest of the study, which if you like the rest of BK's projection puts trial wrap up at mid 2015. I wonder why the enrollment will talke so long ? Any ideas? With 75,000 patients with the condition per month (per BK's post) it seems that roughly a year of recruitment is pretty long. I guess I will have to adjust my timeline to mid 2015 on this trial.
2) There has been some discussion we should hear soon about SPORE grant awards. The 10Q says this:
"Results of these preclinical tests provided to date to the Company are encouraging and BIDMC and Cellceutix wish to move the study further. Cellceutix has provided the requested information from BIDMC that will be used to investigate a Specialized Programs of Research Excellence (SPORE) grant for a phase 2 clinical study of renal cancer upon completion of the successful phase 1 clinical study presently in progress."
If I am reading this correctly it seems to indicate there will be no application for a Spore grant until after the Phase 1 K trial is complete. Accordingly, I have taken that item off my list of potential catalysts for this year.
3) There has been a lot of discussion regarding governance and a BOD. This is from the 10Q:
"In an effort to remediate the identified material weaknesses and other deficiencies and enhance our internal controls, we plan to initiate the following series of measures when we have the financial resources to do so:
We will create a position to segregate duties consistent with control objectives and will increase our personnel resources and technical accounting expertise within the accounting function.
Management believes that the appointment of one or more outside Directors, who shall be appointed to a fully functioning audit committee, would remedy the lack of a functioning audit committee and a lack of a majority of outside directors on our Board. "
My take is that this is governance issues are on the back burner especially in light of the section noting the considerable expense coming up for trials. There also was a mention elsewhere in the document that some additional staff was hired for the accounting deficiency but it was not adequate to fully address it. All that said, it probably is not the best time for this young company to shoulder the expense involved in resolving the BOD and material accounting deficiencies. Leo has been upfront on this in a number of previous filings but I do not remember a specific reference to inadequate financial resources until this filing but I did not go back to check. The bottom line to me is that talk of any appointment of a BOD occurring in the near future appears premature.
Hilarious! Where is Freddy? Oh that's right he just hit Powerball odds again. That's twice in a couple of weeks.
Too funny TD.I am getting a funny feeling in my head too!
JB - Does the user have to wait a minute each time they want to use an app or just the first time? I have always wondered about that.
I'm with you. The low share count will make a position difficult to re-accumulate if either is running. You might get some if you continually hit the ask but it probably will be surging and longs will be holding tight. I use limit orders and don't find these stocks easy to get now. My orders sometimes take hours to fill if I am just a couple pennies below the ask. Sometimes they don't fill at all. I'm holding tight.
When I first looked at the agreement I was wanting 100%. But when you realize how long that might take the 50% deal seemed a no-brainer. You are right - concentrate on their proprietary products and build this small company into what we want. Remember our share count is low - we do not need the same $ that BAT needs to move the share price. And we just bought our first equipment so we are just getting started. I think Big Puff knows exactly what he needs to do to make us all very comfortable with the results.
Yeah I hear you. I'm in deep here, spiffy and the bio. All have good stories and any one of them could make those dreams come true. Hard to imagine what would happen if they all hit.
I am ready to consider anything else from the Van man though. Sounds like he is up to something that we may hear about soon.
Edit: this was a response to Pete post 5108
Maybe so. But when you really think about it with BAT carrying the ball you avoid all the infrastructure required to set up a worldwide enterprise but still get half the sublicensing profit. BAT has 60 affiliates listed, all over the world. So the low tar goes to them via BAT but you still get half the profit. Not too shabby. I bought more today.
I don't read it exactly that way. I read that BAT will own the research and the right to commercialize it unless the research was done solely by xxii or for xxii. BAT will sell a non-exclusive, non-sublicensable right to all the research done by BAT to xxii at a reasonable price. As far as what was in place prior to the agreement, I read that xxii will provide all of that info to BAT.
The competitive issue is not very pressing as I see it. Remember BAT must pay 50% of the profit to xxii for the sublicensed activity. But xxii must pay 50% to BAT for anything xxii licenses or sublicenses too. If I were xxii, I would let BAT carry the ball. Different story in the U.S. though.
The licensing/sublicensing issue won't happen right away anyway as they have to get through the Research term of the agreement first.
I don't know edge. First there is the $3 million. Then, as I read it, you get to sell them the tobacco and add a $100/m ton royalty to the price. If they got the full $25 million royalty at some point that is 250,000 tons provided at a profit independent of the royalty or why sell at all? So there is a profit margin on the sale as well. I do not know the profit margin on the sale. Maybe there is a premium because of the type of special tobacco that it is? I need to give this more thought. Maybe tomorrow.
I think it is quite likely xxii does an extension unless they are really confident on the MSA. I have been looking at the other part of my post - the part about the royalties. Seems we need the MSA to launch our brands and get additional revenue. The licenses/sublicenses will take time but I do like the 50-50 split on anything BAT licenses/sublicenses outside US. And they are huge consumer of the tobacco -10% of global production. xxii is keeping the US for itself unless Reynolds wants to pay double/ton for the tobacco.
Skimmed the 10K and found a few other interesting items:
1) Long awaited info on the detail of the agreement with BAT:
"If BAT exercises the option for a worldwide Commercial License, BAT is required to pay 22nd Century Ltd $3.0 million in aggregate annual license fees over a 2-year ramp-up period, and thereafter, a royalty of (i) $100 per metric ton of licensed tobacco that is supplied to, or grown and ready for shipment to, BAT and is affiliates (other than Reynolds American, Inc. and Reynolds’ affiliates) and all other third parties; and (ii) $200 per metric ton of licensed tobacco supplied to, or grown and processed by, BAT’s affiliate Reynolds American, Inc.
The minimum and maximum amount of annual royalties under the terms of the Commercial License, which commence after the two-year ramp-up period from the exercise of the option, are $3.0 million and $15.0 million, respectively for a period of three years. Thereafter, the minimum and maximum annual royalties increase to $5.0 million and $25 million, respectively, until September 28, 2028. Thereafter, no further minimum royalties are due and the maximum annual royalties due remain at $25 million until expiration of the Commercial License.
Beginning three years from the start of the Commercial License, both 22nd Century Ltd and BAT may license/sublicense rights to any unaffiliated third party for use of the technology outside the United States and 22nd Century Ltd and BAT will equally share all profit from all such licensees/sublicensees. Inside the United States, BAT may only sublicense BAT’s commercial rights to Reynolds American Inc. 22nd Century Ltd may sublicense any party in the United States.
British American Tobacco sells product in approximately 180 countries. In 2012, global production of tobacco leaf was approximately 5,700,000 metric tons, of which BAT utilized approximately 10% for BAT’s and its affiliates’ brands."
2) Additional information about a recent discussion re: Vector and other manufacturers of alternative tobacco products:
"Some major cigarette manufacturers have developed and marketed alternative cigarette products. For example, Philip Morris USA developed an alternative cigarette, called Accord®, in which the tobacco is heated rather than burned. R.J. Reynolds Tobacco Company has developed and is marketing an alternative cigarette, called Eclipse®, in which the tobacco is primarily heated, with only a small amount of tobacco burned. Philip Morris and RJ Reynolds have indicated that their products may deliver fewer smoke components compared to conventional cigarettes. Both Accord® and Eclipse®, which are not conventional cigarettes but cigarette-like devices, have only achieved limited sales. Vector Tobacco Inc. (“Vector Tobacco”), our former licensee, has marketed a cigarette offered in three brand styles with reduced levels of nicotine, called Quest®. With the exception of Eclipse®, the above products are no longer being sold."
3) The latest info on the MSA:
"Goodrich Tobacco has thus far had its cigarette brands contract manufactured by a non-participating manufacturer to the MSA. We are working to become a participating manufacturer of the Master Settlement Agreement (“MSA”), a settlement among 46 U.S. states and the tobacco industry administered by the National Association of Attorneys General (“NAAG”). To this end, we are following two parallel tracks for becoming a member of the MSA. First, in January 2013, Goodrich Tobacco applied to the Alcohol and Tobacco Tax Trade Bureau (“TTB”) for a federal permit to manufacture its own tobacco products. Being a federally licensed tobacco product manufacturer is a primary requirement of becoming a participating manufacturer of the MSA. Goodrich Tobacco’s application has been deemed complete by the TTB, including and a successful TTB field inspection of our manufacturing facility. We expect to receive the permit at any time. On February 26, 2013, Goodrich Tobacco applied to the NAAG to become a participating manufacturer to the MSA.
With respect to the second parallel track, on September 17, 2013, we entered into a Membership Interest Purchase Agreement (“Purchase Agreement”) to purchase all of the issued and outstanding membership interests of NASCO Products, LLC (“NASCO”), a North Carolina limited liability company (“NASCO”) (the “NASCO Transaction”). NASCO already has a TTB permit to manufacture its own tobacco products and is a participating member of the MSA. Consummation of the NASCO Transaction is subject to various conditions including required consents from NAAG and certain attorneys general of the settling states of the MSA. NAAG has been discussing the NASCO Transaction with a small working group of settling states of the MSA for which the Company has answered various rounds of questions. The working group has presented the matter to all the settling states with a recommended course of action which the settling states are evaluating. Upon the entry of a revised adherence agreement of NASCO Products, LLC reflecting the NASCO Transaction, we believe we will be able to close the NASCO Transaction. The NASCO Transaction contains termination rights, including a right for us to terminate the Purchase Agreement, at our sole discretion, if the closing shall not have occurred on or before January 31, 2014. At this time we do not expect to invoke our termination rights."
All looks good to me.
Looks like Freddy hit his powerball odds. He just wasn't playing powerball when he did it.
I agree with JB in that xxii is likely looking at the NYSE MKT vs Nasdaq. Hope they get the Nasdaq. With MSA I think they will.
I was caught by surprise on this. Had looked several times but missed the announcement and when I checked back to see how things finished I was pleasantly surprised. I thought there was a late announcement of the MSA so I was in for another surprise. Next few trading days will be exciting, especially if Joe brings home the bacon on the MSA.
Congrats all.
Thanks JB. Why do you think Quest was used in the NZ study instead of Spectrum?
Not sure of the detail but my guess it has to do with the fact that xxii products are not considered genetically altered. Quest is and I wonder what it means for taste and people's perceptions.