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Biohunter...I'm glad to see you as a moderator here on Sheff's board. You have consistently provided thorough analysis which I find very insightful.
Looking forward to the future here on the board!!!!
GL and GB
Thanks! I thought to ask you only because we just had a conversation(and I respect your technical opinion) on this topic just the other day! Lol
Citrati...can you chime in on the gap discussion in today's action?
Oh ...well the date of the prospectus was dated today. My apology's just knew some on this board were in it....
PTN...filed this morning they may sell 18mill shares...
http://www.sec.gov/Archives/edgar/data/911216/000135448815003948/ptn_424b3.htm
Very valid points!!!
Here's a great article explaining how the Sigma-Tau receptor plays a vital role in many neurodegenerative disease...
Parkinson's Focus
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4281425/
Alzheimer's Focus
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4484039/
Various other diseases and the role of the Sigma-1 receptor
http://www.pubfacts.com/search/Sigma-1+receptors
Thanks CHM!
Being that the cost for ALz is so high, there should be great managed care coverage if/when the drug makes it to market. Especially really good Medicare part D coverage which is usually a tough managed care market for branded medications. Although it will come down to the pricing of Anavex 273 I believe the cost savings vs therapy cost will be substantial enough to warrant easy access for patients.
AIMO
I tried....thanks Fletch for posting it!
AQXP...here's the form 4's
http://www.nasdaq.com/symbol/aqxp/sec-filings
AQXP....I look here for info. I believe it's up to date.
http://www.nasdaq.com/symbol/aqxp/insider-trades
Nice post...I'm reposting so it's a hyperlink ;)
http//www/investopedia.com/articles/stock/06/biotechvaluation.asp
Part B is the phase IIb though. I mean why have a PIIa part a and part b?
See below for my reasoning....
Phase II Edit
Once a dose or range of doses is determined, the next goal is to evaluate whether the drug has any biological activity or effect.[1] Phase II trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Genetic testing is common, particularly when there is evidence of variation in metabolic rate.[1] When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
Phase II studies are sometimes divided into Phase IIA and Phase IIB.
Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).
Some trials combine Phase I and Phase II, and test both efficacy and toxicity.
https://en.m.wikipedia.org/wiki/Phases_of_clinical_research
This is exactly how this phase of our trial is laid out.
Wolf...I believe the Part B of the PII is the open label extension of 26 weeks. However, the patients requested to expand this to 52 weeks. I agree with Jockimo...if like to know if this offers benefits for Anavex. I am reading between the lines but an email I got from IR makes me think PIIb is ongoing and definitely happening. See exert from my email reply from Christine....
".....PART A of the Phase 2a trial is expected to be completed by the end of the year. Anavex is seeking to expand PART B, the extension period, from 26 to 52 weeks at the request of study participants. As of this time, the company has not specified a timeframe to report additional results of the Phase 2a trial.".....
Thanks weathervane...I'm diving into it now. Here's the link since you couldn't post it.... ;)
http://www.ncbi.nlm.nih.gov/m/pubmed/25692950/
That's is typically the case. However the PIIb of this trial was originally set for 26 weeks of continued therapy....they are trying to increase this to 52 weeks of follow up on therapy. I think this bodes well for applying for fast track status.
The phase IIa of this study was further validation of safety and determining what the efficacious dose should be in regards to safety.
Exciting times to come!
Rwingsguy...was this mentioned somewhere?
I would think they would want to uplist so they have access to more capital because starting a new trial will increase cash burn rate. Just my thoughts. Although, starting the trial will add value I know...
Mike...I'm pretty sure we will have to complete PIIb. I would say going straight to market after PIIb is more likely and doing a contingent post marketing PIII study if that were to happen. Of course this is still speculation but I think the odds are more for this than skipping PIIb. The data in PIIb will help better understand efficacy as it relates to dosing and how it performs over time.
GLTY
EBIO....I think the risk here is very high. After looking at their phase 2 data for ocular allergic conjunctivitis I discovered that the primary endpoint for ocular itching was not met. They had good feedback on the secondary endpoint a and those were statistically significant. All this info can be found in the following link. The second link is the PII trial and design info.
http://ir.elevenbio.com/releasedetail.cfm?releaseid=874221
https://clinicaltrials.gov/ct2/show/NCT02082899?term=Eleven+biotherapeutics&rank=3
So the phase III design:
primary endpoint is "morning" ocular itching.
Secondary endpoint a are:
"late afternoon" ocular itching
"Evening" ocular itching
Here is link to study design:
https://clinicaltrials.gov/ct2/show/NCT02492321?term=Eleven+biotherapeutics&rank=1
I'm not saying they will not meet there endpoint as I'm sure this design was based of the findings in their PII.
I have not been able to identify how or if the scoring of ocular itching is different in their PIII vs PII. This could be valuable info for making a better informed decision of holding through data or not.
The date for data release is set for sometime in Q1 of 2016 and not Nov-December. This is from the CEO on August 12th press release. Found here...
http://www.businesswire.com/news/home/20150812005116/en/Eleven-Biotherapeutics-Announces-Patients-Dosed-EBI-005-Phase#.Vc4yX4r3bCQ
I MAY enter on a large pullback and play it as a catalyst play and IF I enter I will not hold through data.
These are just my opinions please do your own DD.
GL
Nice move ;)
Picked up 2,500 at $1.12
Ye it's not a mobile friendly webpage either. Thanks for posting that...maybe sticky?
I meant the reply to be to fourdeuces. He was trying to understand why it said days to cover....
Obviously TC provided more of an explanation than I did in a later post. Good info....
I sent an email about this...will post response when received. Go SYN!
In an effort to keep it a short answer this is the gist of the "need" to cover. The days to cover is computed using the trading volume...higher volume correlates to more days to cover typically and lower volume means fewer days to cover. Shorts need volume to cover....hope this helps!
Good to see ya here BooDog...I agree it's good seeing familiar names...
GLTY!
EBIO...still haven't had a chance to dive into phase 2 in detail and take a look at the PIII setup either for ocular allergic conjunctivitis. As soon as I do I will post to the board. Very volatile stock with the low float. I'm watching it for now...
Testing testing...is anyone here? No one has posted in an hr. Wasn't sure if the board was working or not. ;)
Perfect! Preciate it!
Citrati...can you educate me on the significance of filling a gap either below or above? Just from a chart perspective what makes a gap a /good/bad thing or a target?
Thanks in advance!!!
As always Seel...thanks for that but of info. Been trying to get all the info I can liking to take a position soon. It appears that a bottom may be in. Very nice action today. With a low float news will push this way higher...
EBIO...I was thinking similar. I'm gonna take a hard look at PII results for the program they have moved into PIII now and try to see what the likelihood of success and if so how big the market is. From what I have read so far this is a very niche product and will only be used in advanced stages as early stages are typically handled with antihistamines. Will post when I have more info...
EBIO...also I haven't looked past yahoo numbers but yahoo has institutional ownership at 50%+. Insider ownership 26%. Float at 7 million.
EBIO. .. Been researching th most of the morning. I believe the reason they dropped a few months ago was due to a failure in PIII for Dry Eye Diseas(DED). However, they have a PIII trial for ocular allergic conjunctivitis. The trial is expected to be completed for final outcome measure in November. They had their PII data for this indication published recently. See links...
http://ir.elevenbio.com/releasedetail.cfm?ReleaseID=906999
http://ir.elevenbio.com/releasedetail.cfm?ReleaseID=909445
https://clinicaltrials.gov/ct2/show/NCT02492321?term=Eleven+biotherapeutics&rank=1
SYN... Bottom is in and moving back up...
EBIO....final data collection for their primary outcome measure in the PIII data for severe ocular allergic conjunctivitis is set for November 15
Edit...... November 2015
https://clinicaltrials.gov/ct2/show/NCT02492321?term=Eleven+biotherapeutics&rank=1
Current mkt cap is around 100 mill.
Hahaha....we got allowance meaning that there are no problems with the application and no conflicts. Now we wait to receive issuance. Allowance is approval. The patent will be issued at a later date.
Answer in short yes the patent has been granted
So you think they will have primary results that quick? I was thinking it would be further out as these trials take time to get rolling...do you know the trial design for the study? Perhaps I missed those details somewhere and didn't realize they had been released.
Thanks!
I think the point kld2 is trying to make is the warrant holders once they excersize to get the equity they will be selling because they are way up on their investment. Therefore the total ownership number would decrease. Of course once excersize for they could hold onto shares as well. Possibly selling some but not all. Basically until they excersize and keep their shares then they technically haven't purchased the shares yet.
Hope that clears it up...
Is that the point you are trying to make kld2?