Good points Nidan. The next shoe to drop will seemingly be the deep dive peer-reviewed publication on our ph2a AD results that Dr M referenced at our annual meeting.
We can then add that upcoming medical journal to other recent events including:
• today’s robust & positive S1R publication in Frontiers (which references 2-73 and 3-71 specifically); and factor in all of the other recent positives including
• our new CMO in 2019 Dr Kaufmann (Rett Syndrome leading researcher),
• key job postings at indeed.com last week,
• our 2019 announced ERP Biomarker consortium with BP and Cognision
• our leadership role in precision medicine in the CNS space,
• Rett Syndrome trial DSMB review outcome received as a positive sign (per Janney Montgomery Scott analyst Yun Zhong),
• purchase of $1MM of 2-73 inventory
• “we are working with specialists” to develop a commercial name for 2-73 Blarcamesine,
• RS and PDD and AD researchers/participants asking to extend treatment in current trials and the ph2a trial,
• 4-5 years of safety with generally mild AE (indicative of compound crossing the BBB per Dr M)
• positive reported RWE in ph2a, as referenced in presentations and trial PI Macfarlane media quotes
• AD promising-efficacy especially when dose/blood concentration correlated per Ariana analysis
• according to q3 conf call, the Company believes (awaiting confirmation in current trials) that 2-73/blarcamesine is able to correlate with an improvement in gut microbiata levels (patients had a higher diversity in the gut)
Are US regulators being made aware of Anavex’s progress & the growing body of scientific support for our MOA across a WIDE RANGE of debilitating medical diseases and conditions??
If so, and in light of our long-term safety record and mild side effects and positive real world evidence, combined with the need to treat AD at the earliest stage possible, HOW/WHY are we not yet granted an accelerated approval pathway by the US Food & Drug Administration?
Where is the contradictory scientific evidence negating our MOA?
I can only find solid SUPPORT.
To invoke the great philosopher Michael Stipe from REM, it seems we are pushing an elephant up the stairs.
Pressure is building though, and it’ll likely come from the outside. Our trial patients/caregivers and trial PI’s & S1R worldwide researchers’ influence may someday tilt the scale. https://www.frontiersin.org/articles/10.3389/fnins.2019.00862/full?utm_source=F-NTF&utm_medium=EMLX&utm_campaign=PRD_FEOPS_20170000_ARTICLE
Jobs at Anavex, driven by innovation, problem-solving and fast growth vision:https://www.indeed.com/jobs?q=anavex&l= https://erpbiomarkers.org/ https://www.nasdaq.com/aspx/call-transcript.aspx?StoryId=4282937&Title=anavex-life-sciences-avxl-ceo-christopher-missling-on-q3-2019-results-earnings-call-transcript https://www.frontiersin.org/articles/10.3389/fimmu.2018.02325/full#h2
“I’m really much more concerned because Congress is supposed to have oversight for the FDA,” Brown said. “If the FDA isn’t going to hold pharma accountable, and Congress is getting paid to not hold pharma accountable, then it really doesn’t matter who the president is because it’s really about Congress.”]