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Just did some digging on clinical trials.gov. The only study completion date listed on the main page or in the archives is June 2014. So based on that, it looks like they ended on time. However, the original enrollment target was 429 and was changed to 387 in June 2014. So maybe there was enough of an efficacy signal when the review board looked at the data to not enroll the last 43 subjects?
GLTA,
Murocman
Thanks! I should have read a little farther. Do you know how long was the trail slated to go if the interim analysis efficacy signal had not been met?
GLTU,
Murocman
Was there a press release related to this? I have been digging and can't find anything.
Also, did this constitute an early stop of the trial for efficacy? Again, I can't find anything in the PRs that indicates this.
It seems that the future is bright and hopefully the share price will begin to reflect that when the interim data comes out in the next few weeks.
GLTA,
Murocman
Article out on Reuters predicting early approval of Merck's anti PD-1 inhibitor well before 28 Oct PDUFA.
May be an enabler/catalyst for Oncosec?
GLTA,
Murocman
I don't know the mining business very but but have to believe that big money will come in here at some point and buy out this asset. As I said previously, this is in Warren Buffet's backyard and he has an affinity for 'local' value plays. Not to mention this mine appears to have strong local and state support.
GLTA,
Murocman
Is the completion of the flow sheet something the company is obligated to PR, ie a material event, or could they not say anything until the new NI-403 is issued?
Thks,
Murocman
If the metallurgy plays out here and the economics are attractive, I would not be at all surprised to see Berkshire Hathaway/Warren Buffett take a stake in this or swallow up the whole thing.
He has always been fond of local investments that meet his value criteria.
It looks like we should have a very good idea by early 2015 if this mine is going to obtain the financing it needs to be a go.
GLTA,
Murocman
Science looks pretty good here. Thinking we could move to the $35-40 range on good data on the 12th.
GLTA,
Murocman
Notes should be out tomorrow morning.
GLTA,
Murocman
Briefing docs should be out tomorrow. They usually have a negative tone and cause a stock pullback. If you are going to play the ADCOM, this is the time to get in IMO if you think the ADCOM will be positive.
Most of my DD points to a positive panel. However, I'm going to wait for the docs and see what the tone is before deciding whether or not to take a position.
GLTA,
Murocman
Best case for the company would be a partnership from big pharma that included paying for trials and an ownership stake. That happened for Threshold Pharma via Merck. Short of something like that, an RS and capital raise to fund the science will be needed soon.
The science and results have been good so far, now we'll probably get some insight on how good of businessmen BCLI's leadership team are next Tuesday.
GLTA,
Murocman
Just ran across this company. Looks very promising and potentially very lucrative as an investment!
Looks like they are expecting the results of the feasibility study and project approval this summer?
Any chance a large operator/miner swoops in and buys them up?
GLTA,
Murocman
Neostem only uses adult stem cells so not an issue. They have an agreement and funding support from the Vatican. Lots of room in this pool for multiple players.
GLTU,
Murocman
ASCO Abstracts released on this week on Wednesday. May get more details on the numbers. Could be catalyst. Trade wisely! GLTA.
Murocman
Earnings report will be the next catalyst IMO. Should be around 8 May based on history. This is a solid company that should so very well going forward. Buy the dips and reap big rewards in 12-18 months, maybe sooner if they get acquired.
GLTA,
Murocman
Webcast-MCC Data. Overall a great conference presentation. One thing that jumped out at me was the comment that "we look forward to completing enrollment for our MCC trial and announcing results later this year". At one point, that was on the timeline for interim results prior to the end of Q1 '14. Now it sounds like we may not get interim data so it sounds to me like nothing new until ASCO and the rest of the catalysts in Q3-Q4 this year.
Anyone see it differently?
GLTA,
Murocman
Pretty good battle between buyers and sellers between $3.30-3.50. If buyers win, we probably push to $4+ pretty quickly.
Murocman
The question is how far the big money takes this in the short term?
GLTA,
Murocman
This may be of help to NWBO in the UK, especially since they are already established and have trials ongoing:
After months of lobbying and speculation, the U.K. has unveiled its Early Access to Medicines Scheme, a program that will allow patients with serious diseases to get access to potentially lifesaving drugs before they're approved.
Starting next month, the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) will start taking applications from drugmakers who want to participate in the effort. Under the program, MHRA will first apply a so-called promising innovative medicines designation to successful applicants, and then, once it's satisfied with a drug's clinical data, the agency will green-light the treatment for preapproval use.
The program requires drugmakers to foot the bill for any and all early access administrations, a money-saving move for the U.K.'s National Health Service that isn't sitting very well with the industry. But Ian Hudson, head of MHRA, said pharma will be willing to shell out in exchange for the chance to cull real-world data and forge all-important physician relationships before a drug's proper launch.
"This is a major new development in medicines policy in the U.K.," Hudson said in a statement. "The scheme offers a way by which unlicensed medicines can be available to patients before approval of a licence to benefit public health. It will also enable companies to gain additional knowledge and experience of these medicines in clinical use."
Local trade groups have by and large cheered the effort, viewing it in part as an economic development boon for the country's biopharma industry. Despite housing global leaders like AstraZeneca ($AZN) and GlaxoSmithKline ($GSK), the U.K. has endured deep cutbacks in pharmaceutical R&D over the last few years. This initiative, however, could help establish the country as a world-class place to start and develop a biotech company, U.K. BioIndustry Association CEO Stephen Bates said in a statement, and it "shows the U.K. is committed to an 'all-hands-on-deck approach' to speedily progress promising innovative therapies to the patients who need them."
Bates' group is far less thrilled with the program's funding structure, and the association said it planned to work with MHRA to make sure the lack of government cash doesn't hamstring use of the scheme.
GLTA,
Murocman
What is the IU chat log?
Thks,
Murocman
According to the ASCO website, submitters will be notified if their abstract is accepted in late March.
Murocman
AF is out with a hit piece saying efficacy failed because of no overall improvement in motor skill, cognitive function, etc. I'd expect him to ride this one hard into AD results. If you have gains, guard them closely as their will likely be many more attacks to come.
GLTA,
Murocman
I'm thinking this has a high chance of approval, even restrictions.
If the FDA was going to issue a CRL they would have done it Friday IMO.
If they do get approved with significant label restrictions or have to do another follow up study, I think the short-term high will be in the $7-8 range....still a very good return if you're able to get in around $5 first thing Tuesday.
GLTA,
Murocman
Between bad weather and the upcoming weekend being a long holiday, the company should have the FDA's decision in their hands tomorrow IMO.
If no PR by Friday morning, it's probably not good news.
GLTA,
Murocman
I'm starting to wonder if Oncosec might be looking to deliver MCC results at ASCO? Abstract deadline was last week and those selected will be notified late March.
I guess we'll just have to wait and see.
GLTA,
Murocman
Hard to say. I'd guess if results are compelling the market will take notice. We should get some nice volume and might move to the $1-1.20 range if the market likes the results.
All IMO,
Murocman
Briefing docs will likely be posted on Friday, 10 Jan if the FDA holds to normal timelines. This will be a catalyst one way or the other.
GLTA,
Murocman
Well we ought to know by tomorrow as the CHMP notes are typically released the day after the meeting ends.
GLTU,
Murocman
Don't you think they would be more likely to present results at a medical vice investment conference?
I'm thinking they would want the exposure within the oncology community.
My two cents,
Murocman
Read the Aug '13 PR on the Paraxylene plant and the comments from Vitter, the go and read the 15 Nov story on Forbes.com about the Ford/coke deal.
It sure looks to me like Gevo is involved and there will be a lot more buzz/upward price movement in the next couple of weeks when they unveil this at the LA auto show.
Good buying opportunity on this pullback IMO.
Murocman
Somewhere along the way it was mentioned that more details would be released at the LA Auto show. That starts Friday. Maybe Gevo is restricted from releasing anything until those further details are out. Just a thought.
GLTA,
Murocman
Per the Trans Catheter Therapeutics Conference website, data to be presented at 1:30 PST on 29 October. Abstract is TCT-41.
GLTA!
Murocman
Anybody think the next earnings report in November will turn the tide? Like most, I have been very disappointed with the price-volume action here given the company has an approved product that appears to be gaining traction.
GLTA,
Murocman
However just stumbled across the 10th international Meeting of the Society for Melanoma Research is Philadelphia 17-20 Nov. Looks like a great venue to release some data! Maybe we'll get a PR in the next couple of weeks that Oncosec is registered?
GLTA,
Murocman
Unfortunately there aren't any scientific conferences on Oncosec's calendar ATT for the remainder of 2013 or early 2014.
Murocman
I don't know that he meant last as in there won't be any more. I think it was last as in most recent.
That said, I hope there are partners lining up. Validates the tech and the trial conduct.
GLTU,
Murocman
So I take it you are holding through approval (some or all)?
If it goes to $5 I'll probably lighten up by 1/2 as a hedge.
GLTU,
Murocman
I'm thinking they timed this offering with the knowledge that Ph II Melanoma top line results will be released shortly. I wouldn't be surprised to see them by mid Oct.
GLTA,
Murocman
Just looked through the R&R presentation. It's disappointing that the timeline got pushed to the right for almost everything.
That said, the stock held and finished strong so there must have been some positive sentiment from the presentation.
Thoughts?
Murocman