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Sigma 1 in liver mitochondria
Listened to a CC on GALT about their drug candidate in P2b, shows some promise, but it made me think of 2-73 and the potential with our antagonist. (They are focused on NASH)
First does the liver have any S1R's? I found an interesting abstract by no other than Tangui Maurice, et al. (Our resident genius)
http://onlinelibrary.wiley.com/doi/10.1038/sj.bjp.0704626/full
Its an older abstract, but interesting how our knowledge now has progressed and the answers have filled in over time.
Maybe another disease outside of CNS that Anavex 2-73 or 3-71 could reverse?
sorry RMAT left off the "T"
Just put in "drugs with RMA approval " in search engine, then went through a couple of pages to put the companies together.
I did a search in Bing and put the grouping together. I don't have a link.
Gut Microbiota
Just wondering could an individual's dosing variability be related to
feeding and by their stomach acidity?
TIA
Could Anavex provide the competition lacking over the decades to drive the cost of MS drugs down?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4451044/
Kind of embarrassing that our system of competition has failed us in this regard.
I donated yesterday:) but didn't list my name.
Whiskey I hope your timeline is off by a year...
Reviewing the Gov report on performance for NDA approvals
Final FY 2015 Review Performance
Final FY 2015 review goal performance is presented in the table below. Final performance for submission types that met the goal (90 percent or more review actions completed by the goal date) is shown in bold text. Applications reviewed under the Program have review goals starting from the 60-day filing date, while other submissions have goals starting from the submission receipt date. FDA met or exceeded the 90 percent performance level for 10 of 11 review performance goals in FY 2015. No Class 1 resubmitted NDA and BLA efficacy supplements were received in FY 2015; therefore, this goal category is excluded from the performance goals. More detailed information on performance is available in Appendix A.
Submission Type Goal: Act on 90 percent within
FY 2015 Performance
Original Priority NMEs and BLAs 6 months from filing date 92% Original Standard NMEs and BLAs 10 months from filing date 100% Original Priority non-NME NDAs 6 months 100%
Original Standard non-NME NDAs 10 months 95%
Class 1 Resubmitted NDAs and BLAs 2 months 100%
Class 2 Resubmitted NDAs and BLAs 6 months 97%
Priority NDA and BLA Efficacy Supplements 6 months 94%
Standard NDA and BLA Efficacy Supplements 10 months 95%
Class 1 Resubmitted NDA and BLA Efficacy Supplements 2 months --
Class 2 Resubmitted NDA and BLA Efficacy Supplements 6 months 64%
NDA and BLA Manufacturing Supplements requiring prior approval 4 months 93%
NDA and BLA Manufacturing Supplements not requiring prior approval 6 months 96%
My rosy outlook, Rett trial data complete by Q1, NDA/BLA summited by March, Fast track, Breakthrough, Marketing Authorization Application drug access by Sept. 30 2018.
Cheers.
FYI from my Scottrade account.
Recognia has detected a "Symmetrical Continuation Triangle(bullish)" chart pattern formed on AVXL. Indicates that the price may rise from the close of 4.67 to a range of 7.20-7.80.
Bummer. Looks to be a ways off before it launches. You might roll some money into avxl, they have a lot of catalysts by the end of the year. You should do some diligence on the company if you like science.
Nope all in avxl
Ladenburg conference
http://wsw.com/webcast/ladenburg3/vcel/index.aspx
Sometimes the webcast rolls from one company into another. I think this is the presentation prior to Anavex. But might be in another room and not work.
Thanks, wonder why Nasdaq is not showing anything.
Comparing AXON short interest to AVXL. Anyone notice that Nasdaq shows no short interest in AXON. Would anyone care to offer an explanation, TIA.
Patent infringement
LOL thanks for the laugh.
Another Big Potential
DMA Duchenne's muscular Dystropy, caused by recessive X21 gene.
DMD is caused by a mutation of the dystrophin gene at locus Xp21, located on the short arm of the X chromosome.[7] Dystrophin is responsible for connecting the cytoskeleton of each muscle fiber to the underlying basal lamina (extracellular matrix), through a protein complex containing many subunits. The absence of dystrophin permits excess calcium to penetrate the sarcolemma (the cell membrane).[8] Alterations in calcium and signalling pathways cause water to enter into the mitochondria, which then burst.
Kind of sounds like it might be right up our alley:)If our drug can bypass the mutation and return cells to Homoeostasis, balancing CA+, preventing water from entering mitochondria, maybe we have a winner.
Has anyone considered TEDx as a way to spread the word?
I was recently in touch with a group putting on a small verse of Ted, but their timeline for admission for speaking was in June.
Xena I agree there is potential for our drug in Japan and I am sure we are working towards development there. My biggest worry is a rouge country reverse engineering our product, not paying any attention to the patient and trying to undercut us. I suppose that keeping the price reasonable would help avoid this situation.
Takeover talk, how about this scenario, Anavex contracts with Sanofi, to manufacture the drug with their excess capacity in Canada, European manufacture in Sweden (isn't that where the drug was made for testing)Sales through an offshore company (Horizon phara)all with favorable agreements that allow the company to take back the drug for non-performance of their duties.
Horizon because they have gone offshore to get a low tax rate and could cut a much stronger deal with Avavex on the distribution side.
To me this would bring a higher valuation to our company, compared to a merger or acquisition. Plus I just don't trust Biogen/Idec to do the right thing.
Pricing, again using the UBS market of around 40b per yr. Divided by 6 million patients with Alzheimer; 6,500/patient per year would seem a reasonable price.
Thank you for your valuation summary.
I based mine on Dr Misslings discussion of what UBS had valued the AD potential market size. They (UBS) estimated 37 to 60 billion per year. Using a quick and dirty method of valuation, say 40 billion of gross revenue, a market cap of 200 billion for just Alzheimer's would not be unreasonable (5 x gross). Are there 5 or more disease states out there that could have a positive outcome... that's why my estimate would be closer to 20k/share. Someone asked if I would be willing to sell at 500, i said no, not when it's worth 10k.
Not sure if the compound 1066 a Sr1/Sr2 ligand are agonists or antagonist.
But this compound looks to address opidoid emergency by affecting visural and neuropathic pain. Excellent candidate for a fast track.
20k per share seems like a fair price
Biotech Analyst gave AVXL an 18% chance of successfully treating Rett...
Yes I did state that NOBLE's PHD analyst had decided what was an achievable number, but would like to continue to expand upon his research. The data that he quoted was from Dec '16, and we have had continued success in our trials, and confirmation from Dr. Missling that our trials are designed to fail quickly. With each passing day we are building upon the likelihood of success, and with all the data that I have read, am more encouraged than an 18% chance. I would venture a guess much higher.
On another note, I contacted IR about expanded access potential for a relative of mine that has Parkinson's, and got the opportunity to discuss the company's position on Expanded/compassionate access.
The reply was that the company is focused on a methodical progression of research, and not interested in getting involved with expanded access. I told them that I was concerned with the pace that the FDA has shown in the past regarding approval, when we have a drug that has shown to be safe, and effective.
IR pointed out that the company has already achieved many milestones (if you review what they have done) and I would have to agree. They stated information will be forth coming as soon as available and reiterated that trials are still planned for 2017.
more exposure
Kld I agree that the chances of new information are low, this is not a scientific conference, but each time Dr Missling presents; his message is becoming more refined and articulate.(Checkout the NOBLE conference, he did a great job)
Exposure to uninformed investors that are ready, willing, and able to buy probably the most important job of the CEO. For weeks minions on the board have decried the lack of communication, this should help increase demand for the stock, reduce supply for the market makers to manipulate and ultimately increase the underlying price of the stock.
Go Avavex
The Noble research report had the chance of approval at 18% for Rett syndrome.
A little less for AD, not sure where/how he came up with those, but adaptive trial brings the chances higher.
Dado thank you for posting. Is anyone going to the conference able to tweet a live feed? Wish they would provide a link to a webcast.
Karm is a B Adam, hope you were part of the 32% short of float. Remember the rant you had with George. Haha
Why I think hiring is so beneficial for Anavex going forward.
I was involved in a Offer in compromise with the IRS (big gain in the market, reinvested and loss the gain)I used the services of a Tax fixer. He had 25 years experience with IRS, a regional manager in the settlement division.
Long story short, it's amazing what someone with inside knowledge can do for your cause. They know the people that are asking questions, they understand the concerns raised and can quickly give an answer.
In my opinion this was a well thought out hire, and should help speed us along on our journey towards approval.
GLTA