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In researching Blockchain Global found this:
M&A, Investment and Incubation
Having participated in blockchain focused deal-flow with professional funds and investment houses such as Shape Capital, Collinstar Capital and Ironside Capital, Blockchain Global and its network have, since 2014, invested in a worldwide portfolio of dozens of blockchain enabled companies and projects.
Beyond backing profitable blockchain startups, the company co-invests with strategic cornerstone investors in M&As that bring blockchain technology into small and medium cap public companies, giving the combined entity access to capital markets, and providing retail investors exposure to exciting opportunities, leveraging potential unstoppable and borderless technologies.
It would seem that an alliance with them will indeed bring GENE into the blockchain technology. Not sure if the investing is with them as well or not.
Hope they start trading soon as I am long GENE and have some money invested. Hopefully news will be good and stock will take off pre-halt value.
MELBOURNE, Australia , Feb. 12, 2018 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX:GTG) (NASDAQ:GENE) (“Company”, “GTG”), wishes to advise that the Company is presently in discussions with the ASX regarding the possible application of ASX Listing Rule 11.1; its structure / operations in compliance with ASX Listing Rule 12.5 and whether a strategic alliance with Blockchain Global Ltd to explore the application of Blockchain technology (distributed Ledger) to provide efficiencies and new opportunities leveraging off the GTG existing genomics business would result in a change of activities of GTG. While these discussions are continuing, the ASX has required that GTG continue in suspension. GTG will provide a market update as soon as it is able to conclude that review by the ASX.
Interesting, in the earnings report, the company said "have $127M in cash" and "The increase was primarily due to net proceeds of $88.2 million during the first half of 2017 from sales of common stock under an at-the-market sales agreement."
It would seem that DVAX has been selling stock slowly. This also would indicate that a stock offering should be of lesser size as there is some cash in hand already.
Now on to approval and take it from there.
Interesting Info from SCHEDULE 14A INFORMATION (first line is important)
"Although the Board has no immediate plans to issue the additional shares of common stock it desires to have the shares available to provide additional flexibility to use its common stock for business and financial purposes in the future as well to have sufficient shares available to provide appropriate equity incentives for our employees. The additional shares may be used for various purposes without further stockholder approval. These purposes may include raising capital; providing equity incentives to employees, officers, directors, consultants and/or advisors; establishing strategic relationships with other companies; expanding our business through the acquisition of other businesses, products or technologies; and other purposes. For example, we will need to raise substantial additional funds to, among other things, finance our operations, clinical trials and the initial commercial activities for our product HEPLISAV-B™, if it is approved. In addition, in view of the recently reported positive results in our lead oncology program, we anticipate we will continue to require additional capital to conduct later stage clinical trials. Thus, we will need to obtain significant amounts of additional capital and the additional shares may be used for a financing if we have an appropriate opportunity. Although we may pursue other sources of funding, such as corporate collaborations and partnerships, if we are not successful with these efforts or if our Board otherwise determines that a financing through issuing additional shares is attractive, we want to be in a position to act quickly depending on market conditions. If this Proposal 1 is not approved by our stockholders, it is possible that financing alternatives for the Company may be limited by the lack of sufficient unissued and unreserved authorized shares of common stock, and stockholder value may be harmed by this limitation. In addition, our success depends in part on our continued ability to attract, retain and motivate highly qualified management and clinical and scientific personnel, and if this Proposal 1 is not approved by our stockholders, the lack of sufficient unissued and unreserved authorized shares of common stock to provide future equity incentive opportunities the Compensation Committee of our Board deems appropriate could adversely impact our ability to achieve these goals."
Is close, I got the number from:
http://www.nasdaq.com/symbol/dvax/short-interest
Is showing 6'269.347 as of 7/14/2017 In any case there will be lots of people covering. I believe it takes a lot of fortitude to even think on shorting this stock on Monday, whomever tries will get crushed.
Good luck you all longs.
For what is worth, my Fibo retracement levels for Monday are: $14.07 (61.8%); $17.13 (100.0%); $22.12 (161.8%); $30.26 (261.8%) these are based on Thursday levels.
Hoping it will hit the $22.12 and depending on momentum will wait for the big prize .
Lets cross fingers ... remember that there are more than 6 Million short shares out there which will likely be flushed out.
Will sleep little tonight
Institucional buyers traded more than a million shares in range $14.62-$18 after hours with 1.662.536 millions changing hands.
Expect a $16 opening. Price will not go down with such a number of floating shorts and calls covering that undoubtedly will be triggered.
Remember this stock has been $30 (September 2015) before the disappointments where reported. Now there is a clear road to approval PLUS SD-101 (this is VERY important).
How high can it go ??? Difficult to say, Cowen analyst Phil Nadeau rates DVAX an Outperform with a $45 price target (more true now that the chances of approval are high).
We will see .... will keep my finger at the ready on Monday. In any case, is all good news folks ..., I am going to Thailand (Bangkok and Phuket) to celebrate.
Good weekend !!!
Vote was actually 12 Yes, 1 No, 3 abstain
Likely will be approved with required robust surveillance study.
Price should be in the $14-$16 range before FDA decision (some of the uncertainty is now gone). If FDA decision positive we will be in the 20's.
The FDA has to balance the "public health" aspect of any drug. That, simply put is risk-benefit. The drug is superior, no question about it. The question is: is it riskier than the current SOC ?. The data gathered did not, and cannot, answer that question as was not designed to qualify MACEs.
In the FDA own words the number was small and, in DVAX words "Framingham Risk Score model for coronary heart disease event prediction. Accounting for risk factors in the population-based risk estimation models increased the expected number of events over the age-, sex-, and race-adjusted estimates. The number of observed events was similar to or lower than predicted in each trial and in HBV-16 and HBV-23 combined".
The issue is that in the Engerix-B arm the incidence was much lower.
The AdComm has two venues: request further tests focusing in the Cardio safety (CRL with no approval) or, approve with Post-Marketing Surveillance Plan (which DVAX suggested on their proposal).
I firmly believe that the latter rather than the former will be the outcome as, in reading in NARRATIVES OF POTENTIAL MYOCARDIAL INFARCTIONS, most of the events occurred to people that were already sick. For example: "A 62-year-old white man with a relevant medical history of coronary artery disease with an old lateral myocardial infarction (MI), dyslipidemia, multiple prior coronary stents, and obesity experienced an ST elevation myocardial infarction 319 days after the second HEPLISAV-B injection. " or "A 69-year-old white woman with a relevant medical history of obesity and dyslipidemia experienced a non-ST elevation myocardial infarction 208 days after the second HEPLISAVB injection. " or "A 46-year-old white man with a relevant medical history of sleep apnea, hyperlipidemia, hypertension, and obesity experienced an acute MI 175 days after the second HEPLISAV-B injection. " or "A 64-year-old white woman with a relevant medical history of type 2 diabetes mellitus, dyslipidemia, hypertension, heart palpitations, and sleep apnea experienced an event of coronary artery occlusion 14 days after the first HEPLISAV-B injection". I am just copying the FIRST 4 narratives (not cherry picking here "
One cannot blame DVAX for recruiting subjects with prior medical history, and, bedsides, one cannot forget that there was a, difficult to explain, unbalance with the other arm.
I am optimistic of the outcome and, obviously putting my money where my mouth is. Hopefully the AdComm and FDA will give DVAX the opportunity to prove that that Heplisav-B is not causing any MACE's and the number of events (as the study DVAX made suggests) are normal and low.
Went out of predictions business long time back. I just read the documents and made the best decision with a positive mathematical expectancy.
With FDA there is simply no guarantee.
After reading the FDA Briefing Document and, importantly, the consultant opinion, I believe the probability of approval is in the Long side. I was expecting a $12-$14 price prior to AdComm (unfortunately this does not seem to be panning out). A positive outcome (vote) would value the stock 20-30 % higher. Taking the lower value and a 25% up-marking after AdComm (if positive results) we should have a $15 SP.
FDA approval should take the price to $18-20 (I am not factoring in the value of SD-101, which seems to be forgotten at the moment).
In any case, I am taking positions with these numbers in mind. Hope it happens.
Note: I have been holding a sizable position in DVAX for 8 months now.
It seems to me that we are "on the road" to approval. If this is not approved I don't know what would . I have seen MUCH worse than this in other drugs (in other illness) and where approved.
The possible drawbacks far outweigh the benefits.
You all longs have a good day (I am having one ).
Questions for the consultant
Consult 1
1. In the “Evaluation of Acute Myocardial Infarction and Major Adverse Cardiovascular Events in the Phase 3 Heplisav Clinical Trials,” the Applicant uses the following tools to assess cardiovascular risk: 1) identification of reported events of AMI in the safety database and multivariate logistic regression analysis to assess risk factors associated with MI in Study DV2- HBV-23, 2) a three-point MACE analysis to identify serious cardiovascular events in the three Phase 3 studies, 3) comparison of observed to expected number and rate of cardiovascular events in studies DV2-HBV-16 and -23, and 4) discussion of the Bradford Hill criteria for assessment of causation applied to the three-point MACE analysis. Are these the appropriate tools to use to evaluate the cardiovascular risk following Heplisav? Are there any additional tools you would use to assess cardiovascular risk associated with Heplisav?
Consultant questions:
Response:
• The tools listed, as well as the applicant’s analysis of absolute risk and risk difference, seem reasonable in evaluating cardiac risk.
• In general, comparing rates of observed cardiovascular events in the study population to expected event rates in the overall population raises the issue of comparability. However, on its face, the sponsor’s argument that MI and cardiovascular death rates in the Engerix-B group appear lower than predicted seems plausible.
2. Please comment on whether the appropriate cardiovascular outcomes have been selected for inclusion in the analyses. Specifically, we have the following questions:
? In order to identify subjects with myocardial infarction, are SAEs with preferred terms in the MedDRA SMQ narrow for myocardial infarction the most appropriate criteria? ? What, if any, additional preferred terms, or other criteria, would you recommend using to identify subjects with probable myocardial ischemic events?
On Myocardial Infarctions:
Based on this systematic evaluation, we found that myocardial infarctions and MACE outcomes occurred:
• In persons in whom they would be expected, who had a high burden of cardiovascular risk factors with advanced and often multi-vessel obstructive coronary artery disease;
• With no evidence by clinical annotations and cardiac catheterization data for
inflammatory/immune-mediated vasculitides or myocarditis;
• With no evidence of a hypercoagulable state as other venous or arterialthrombotic/thromboembolic events were balanced;
• Without close temporal relationship to vaccination administration;
• At rates in the HEPLISAV-B group that were similar to or lower than predicted background.
The observed numerical difference between treatment groups in the occurrence of events coded to the MedDRA preferred term acute myocardial infarction in HBV-23 is an isolated finding in the HEPLISAV-B database that appears most likely explained by random variation resulting in an unexpectedly low number of events observed in the Engerix-B group in HBV-23.
It would seem that the docs are favorable ...
An important section regarding cardiac events:
"7. What is your assessment of the cardiovascular risk associated with Heplisav? What, if any, problems have you identified with the Applicant’s conclusions with regard to the analyses they have presented?
• There are a number of factors that make us think that this is not likely to be a reliable safety signal.
i. An imbalance of MI that was not statistically significant was observed in studyHBV-23. This imbalance was not observed in previous smaller studies; however,HBV-23 study population included a higher percentage of subjects with higher cardiovascular risk.
ii. Analyses of adjudicated, confirmed stroke, cardiovascular death and MACE events in HBV-23 showed similar directionality (e.g., RR> 1.0), but none of the analyses showed a statistically significant difference between the two treatments. The cardiovascular death events were few and the RR was not robust.
iii. The imbalance in cardiac events did not occur shortly after the first or second dose of vaccine; according to the Kaplan-Meier curve for MACE events, the two
groups appear to separate only after 100 days. Thus, we agree with the applicant that there is not a close temporal relationship between vaccine administration and cardiovascular events. This timing is particularly incompatible with attribution to the adjuvant.
iv. Non-clinical and clinical studies failed to reveal a plausible mechanism for MI.
The risk of MI could result from accelerated atherosclerosis, sustained increase in blood pressure, or some prothrombotic state. None of these is in evidence.
52
v. The sponsor’s assessment that the event rate in the control arm is spuriously low is plausible. It is also plausible that the observed between-group difference is spurious.
• Based upon the low likelihood that there is a real safety signal here, and the low absolute risk that these data suggest, we would label the finding in section 6 only and consider ways to monitor this risk post-marketing through some passive surveillance system."
Agreed. The thing is what is "good". Is a long discussion, but for us investors dilution is almost never a good thing (we think in relatively shorter terms than management).
The question is: Will this take place in-between AdComm and PDFUA dates? Or right after PDFUA ? or some time afterwards ???
as it was rightly mentioned: "timing is everything".
We had a good move today with institutional buying ... Hopefully will be in the $12 + range prior to AdComm.
The vote on safety Is the critical part (efficacy is a slam dunk).
Good luck to all long-suffering-in-silence investors . The time is here !!!
Extra shares are not necessarily a bad thing, however with a FDA approval in hand DVAX can easily raise capital by other means. Also, SD-101 is funded till 2018.
What worries me is if the shares can be placed before the FDA meeting. Let assume the meeting on the 17 ends up approving them and AdComm is positive. Would DVAX announce a new issue BEFORE the FDA meeting?. Or, rather this will happen after the meeting? Or this will happen some time down the road?
I would hate to wait all this time to see a good SP being brought down by delusion just at the "best" time for us long-term investors.
Any thoughts?
We are in the final stretch for AdComm. Price should firm up and then the week after meeting we will see results. If positive we will be looking for a good leg up ($12-$14).
I also voted NO for more shares. If results of AdComm are positive and FDA approves there should be no need for more shares out there.
Good luck to all longs.
Yup, latest thing I would do is short DVAX at medium term. Action today likely caused by short-term traders.
SP of $10 does not make sense prior to AdCom. Price last year (WITOUT SD-101 RESULTS) was around $16 in August, went down to around $10 when AdCom was cancelled.
Come present time: SD-101 can be a blockbuster (actual results are extraordinary if they probe in a larger cohort). If we assume ONLY a $3-$4 value for this, the stock price today (given same circumstances as last year prior to AdCom should be $16 + $3 =$19.
Now let's assume that we are cautious and valuate the company with what was the price when the AdCom was canceled $10 + $3 = $13. Which, of course, is low as we know there will be an AdComm and, more importantly, management has had lots of time to prepare and respond the questions given by FDA. IMO the probability of approval is much higher this time.
So, price should be around $13-$19 before AdCom, if approved should easily jump into the high $20's.
Nice recovery today. We need volume to break $10 barrier and launch.
It depends on the valuation method one uses and, of course, the peak sales projections and if one takes into account SD-101 current status (or potential ?)or not.
As you can see, a very difficult exercise. As an investor I have made several assumptions and could go through the math; however, the bottom line is I expect $12-$14 before AdCom, if minute readings are encouraging expect 20-30% appreciation before PDUFA. Calling the mid-point this would be around $16+.
If approved I am forecasting $20-$30 range. Cannot be more precise since a good result would mean that SD-101 will be properly founded and the company will be an obvious target for takeover (read GSK) which, I am sure, will encourage more investors to join-in the party.
These are simply my working numbers and am long DVAX for long time now. Hope payday will come this time .
Good luck to the longs !!!
Great news.
Looking forward to review the minutes with, hopefully, more information on latest follow up.
Coach,
Agreed, moreover If I was NTRP I would be investigating as well "slow delivery" methods. The technology is there to deliver drugs at a very slow rate for extended periods of time into the blood stream and/or any other target tissue. If what does the trick is a low(er) dose, this could be delivered continuously for large periods for evaluation.
What really matters here is that it demonstrably works, the fine-tuning hopefully will be incorporated in P3.
I wish they will release the longer-term treatment data soon, it will be enlightening.
This can explain why the 40 ug/M2 dosis results were inferior (the Downregulation mechanism was known before). Some people has cited the lack of higher dose reports as something "fishy". Is highly possible that lower dosis can produce even better results. Question is what would be the best application frequency.
"Downregulation is particularly significant at higher doses of bryostatin, e.g., >30 µg/m2/week. Downregulation may potentially complicate the therapeutic use of bryostatin 1 because it could produce effects that are different or even opposite from activation. Therefore, it is important to optimize clinical trial protocols to maximize the lower dose biochemical effect of PKC? activation."
MaxTok:
Both options have good leverage, however the implied volatility is too rich for my taste (114 % and 110.9 for the $10 calls for June 16 and 21 July respectively.)
I would purchase options in spite of these large I.V. if there were a certain binary catalyst before the expiration time. What we have in the future are the reports for 17 weeks and the proceeds to start P3 (well and the potential of BP intervention.). However, we don't know when any event will take place.
So, I believe that is better move to straight own the stock in spite of the money being tied.
After reading some of the results of Dr. Alkon with mice (and the related papers), there is no doubt in my mind that if the same/similar effects can be transferred to humans this drug is a blockbuster. The results of PII positively demonstrated that (be p<0.07 as opposed to p<0.05, is not important). These results were obtained when very sick patients were given SOC (i.e. NET improvement when the placebo is not really a placebo for some groups).
Now, if the dosage can be better adjusted with periodic monitoring (to achieve maximum effect) I am sure the results will be substantially better. Not to mention if the drug has cumulative effects (patents improvement with time).
We will know soon. The science is there.
I have been happily adding as the price goes down and own now a substancial chunk of shares. So my disclaimer is that I am very long NTRP.
Let's relax, wait and expect good news after 17 week results are analyzed & digested.
I am an investor not a trader, and can wait for the science to finally impose itself. My biggest doubt honestly, after reading some of Dr. Alkon papers, was if the results with animals would translate to humans. I got an (positive) answer after Phase II.
BTW, it seems that some people are expecting something that PII is not "Phase II lasts several months to two years and is when general effectiveness and side effects of the drug are assessed. In this phase, researchers determine the correct dosage and mode of delivery." As far as I am concerned this has been fully achieved.
So, I continue being long and probably will add up after 17 week results are made public.
This not going anywhere. The results were positive. Period. And the whole thing is based on lots of scientific research of public domain.
Seems that somebody is sore.
"On May 1, 2017, Neurotrope shares fell from a previous close of $18.81 to a close of $6.07 after the Company disclosed what it referred to as "positive results" for its Phase 2 study of Bryostatin-1 in patients with moderate Alzheimer's disease; following this disclosure, news outlets were quick to point out that one of the patient groups did not meet the primary endpoint, and that the Company's "positive results" focused on the results for a lower dose of the drug. "