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The notes will provide the committee and the public what the FDA is concerned about and what they would like the committee to focus on.
Based on the last ADCOM, I would expect it would be along the lines of issues, difficulties and problems associated with the actual implant and if the committee thinks what has been done as far as studies is safe, practical and something clinicians would be likely to do and patients would be willing to receive.
Also, the notes usually have a negative tone. The less so, the more bullish they are viewed.
GLTA,
Murocman
Volume indicates something is brewing. Maybe we'll get that takeover news before year end after all?
GLTA,
Murocman
Volume and price action so far indicates the market is thinking the results will be good.
GLTA,
Murocman
ADCOM briefing notes should be out on 7 or 8 January. These could be a significant catalyst depending on their tone. They usually tend to be negative.
If they are, this would be a chance to add shares at a discount if one thinks the panel will be positive.
If the notes have a positive tone, the stock will likely move up strongly.
GLTA,
Murocman
ASH is coming up fast. Abstracts wii be released this week. Although the buzz is about oncology, this would seem to be great venue to release data on their anemia drug. I guess we'll see if anything comes out when abstracts are released on Thursday?
GLTA,
Murocman
Read it. I still think a likely higher interest rate environment and sluggish worldwide economic activity could make for tough sledding in early 2016.
GLTA,
Murocman
The article below highlights the tough environment Niocorp is going to be in as far as attracting financing for Elk Creek. They have a high quality asset but also a high CAPEX, and the timing of the BFS and seeking capital may make the development of this project much slower than any associated would like. It will be very interesting to see how it all plays out.
http://www.newsmax.com/Finance/InvestingAnalysis/Smaller-Miners-commodities-prices-mining-metals-prices/2015/09/25/id/693335/
GLTA,
Murocman
This article gives me a bit of pause as far as my optimism heading into this readout. I did not get a chance to listen to the earnings call so did not realize the company had changed the dose level. Anyone else have any thoughts on this?
http://www.orf-blog.com/biotech-portfolio-updates-thoughts-on-ongoing-correction-and-upcoming-catalysts/
Trevena – Important readout in September
Next month, Trevena will report Phase 2b results for TRV130 in post-operative pain. The trial is comparing 2 doses of TRV130 to morphine and placebo. While TRV130 will likely be superior to placebo, superiority over morphine in terms of efficacy and/or safety is crucial for commercial success. In contrast to previous studies that evaluated fixed doses of TRV130, this trial uses patient-controlled analgesia (PCA) administration of TRV130 and morphine. This means that patients can control how much drug they receive up to a pre-defined limit.
On its recent earnings call the company disclosed a decision to increase the dose after an interim look at the data. This caught investors by surprise (although the company previously disclosed the trial has an adaptive design). Some interpret the company’s decision to dramatically increase the dose (from 0.1mg to 0.35mg every six minutes) as an attempt to improve efficacy (pain relief) after a disappointing efficacy interim readout.
The decision to escalate TRV130’s dose can stem from insufficient efficacy, good tolerability or both. My bet is on option #3 because management sounded upbeat at a recent investor conference (which means the trial is not a complete flop) but on the other hand if the low dose of TRV130 had been superior to morphine there would have been no need to dose-escalate. Next month’s results will have a dramatic impact on the stock as they will either validate or disprove Trevena’s bull case of a safer, more effective opioid.
GLTA,
Murocman
Enrollment complete by the end of this year and data mid-Q3 2016 per company website.
GLTU,
Murocman
Obviously there are no guarantees and the biotech world is rife with trial failures and disappointments. My review of the data to date indicates there is a good chance of success. The trend data of TRV130 vice placebo and morphine is very favorable and the p values are very low.
Obviously all should do their own DD, but I'm very comfortable with my investment here.
GLTA,
Murocman
Effectiveness filing today for the shelf is dragging on the stock IMO. I fear this will continue if the company dilutes into positive. Will have to keep a very close eye and trade wisely.
GLTA,
Murocman
I think PTN wins regardless of Addyia approval or denial
If Sprout's drug is approved, PTN will benefit from the buzz and being the only public company n the sector. If it get's disapproved, they have the market all to themselves with a much more attractive product. Seems like it should do well either way.
GLTA,
Murocman
I did not get to listen to the call but if the company is confident they can get a Phase III approved based on their secondary end points and trend data, this might move towards old highs.
It may take a successful meeting with the FDA before that happens.
Thoughts?
Murocman
Just doing some searching trying to see when and where PIRS might present results from their PH 1 Anemia trial. This looks like it would be a premier event in which to present their data:
http://www.globaleventslist.elsevier.com/events/2015/10/tenth-cooleys-anemia-symposium/
Deadline for abstracts is this coming Friday.
GLTA,
Murocman
His last buy was 12/2013. While bullish that he holds such a large position, it will be more telling if he added in the offering that just closed. We should know within a week or so if he added any shares.
GLTA,
Murocman
Link?
Anyone having an issue buying shares? ETrade still only accepting phone orders.
GLTA,
Murocman
Tried to add to my position in my Etrade account and got a message that I have to call. Never had that happen before with this stock.
Murocman
This would be good in the five year horizon for Niocorp and it's shareholders but I still think we will/would get to the same value sooner(1-2 years) if the company remains solely focused on the Elk Creek asset and it's development.
Too much CAPEX and overhead in a Largo merger and trying to buy and develop another asset for my taste.
GLTA,
Murocman
I can't say that I'm much of a fan of a merger with Largo. It dilutes the value of the mine and therefore, would cost shareholders in the way of lost value on a pure Niobium play IMO.
If that's going to happen, I'd rather see an outright sale to a large, established mining company as I think there would be a higher premium.
GLTA,
Murocman
Based on what?
Needs to get through and hold above resistance at $0.65 and $0.88 before it has a shot to run to $1+. Watch the volume and the trading action as they will tell the story. If the stock runs past $0.65 on heavy volume and can close in the $0.70's early this week, especially on no news, that would be very bullish.
The set up is good. Now we're looking for follow through.
GLTA,
Murocman
Needs to get through and hold above resistance at $0.65 and $0.88 before it has a shot to run to $1+. Watch the volume and the trading action as they will tell the story. If the stock runs past $0.65 on heavy volume and can close in the $0.70's early this week, especially on no news, that would be very bullish.
The set up is good. Now we're looking for follow through.
GLTA,
Murocman
AQXP
Data coming very soon here. Great institutional (Pfizer) and Biotech heavy hitter (Baker Brothers) Investment
Link for DD: http://aqxpharma.com/sites/default/files/pdf/2015_pdf/aqx_corporate_presentation.pdf
Volume is thin but that could change quickly with good data.
I like the prospects and have building a long position.
GLTA,
Murocman
Data should be coming very soon. I like the prospects here and have been building a position.
Nice ownership by biotech heavy hitters (Baker Brothers) and big pharma.
Am expecting good things from the data and a nice boost in trading volume and share price!
GLTA,
Murocman
AQXP. Data coming very soon for COPD and inflammatory pain relief. Large holding by Baker Brothers and investment by Pfizer and J&J. Cash situation is good and chart looks great. Only negative I see right is thinly traded. Taking a starter today.
GLTA,
Murocman
Does HQ move to US affect TSX listing? Just wondering if at some point, the company is going to have to be wholly U.S. listed because they are no longer a Canadian headquartered company?
GLTA,
Murocman
I was thinking this could get to the $0.50 area on good Epilepsy data and the probably drift back to the 30s in June/July unless some kind of news or financing. After that, I'd expect a runup to the $.60-0.70 range in anticipation of Alzheimer's Data. After that who knows. PRAN hurt me badly so I'd probably not hold much into data without some kind of interim positive data.
GLTA,
Murocman
See post #5119, second to last line of conclusion before the table. $2 level upside after data in mid-2015.
GLTU,
Murocman
Read it again. He said $2 after good P3 data. No price target for approval.
Murocman
Anticipation of improved earnings, strong sales outlook and end of dilution (all today after the bell). Also possible FDA 501K expanded use being approved in the near term.
Murocman
That was supposed to be after the close today...IPhone buffoonery.
AMDA Moving strong on heavy volume into earnings after the isr today.
Murocman
The publish date on that is Nov 2014. Go find something relevant and try again.
Murocman
AMDA. Earnings out tomorrow. Could be a runner if the company delivers on its forecast. Currently holding a long position.
GLTA,
Murocman
What news is that? Don't see any PR?
Murocman
Buy or sell?
CDN or US$?
Question for you who are In the land of Moosehead.
Is there any specific timeline, waiting period or filing paperwork required to move from TSX-Venture to the TSX big board?
Just wondering how fast this move can happen?
Murocman
I wouldn't waste your time with Hagel. He didn't do much for the state as a Senator and only touts his Nebraska roots when it's convenient for him.
Murocman