Hoping for the Best for All30 May 2019 15:11
I have been following these discussions for several months since investing in MTFB, both from a confident investment perspective, but also for altruistic reasons. I have found the ‘chat’ extremely interesting and in certain instances vastly informative. There are some excellent posts by knowledgeable, experienced and well-informed people. Conversely, (in my opinion) a few are repetitive, disingenuous and ill-informed, from person(s) who, are trying to discombobulate the situation, by their inculcated approach.
However, at this moment in time (unless we are/have been involved in the statutory process) we can only speculate as to the FDA (who must follow due process) rationale. Although, if there are any ‘conspiracy theorists’ amongst us, I’m sure (as previously posted) they may advocate that the ‘government shutdown’, could have had a significant impact on the current situation.
www.ahdbonline.com/web-exclusives/2685-government-shutdown-impacts-fda-drug-approvals
Government Shutdown Impacts FDA Drug Approvals;
‘Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.’ Etc etc.
Several pharmaceutical companies that had hoped for early 2019 approvals now hang in suspense, with some inside the government speculating that the political crisis may not be resolved for weeks to come. As a result of heavy backlogs, prescribers and patients will likely face extended wait times for approvals even after the restoration of the agency to its full staffing once the stalemate is broken and government business resumes. Under the Prescription Drug User Fee Act, the FDA uses the fees collected from drug manufacturers to fund drug reviews and approvals and is currently using leftover monies to finish working on applications submitted in FY2018; however, that money is expected to run out in early February.’ Etc etc.
https://edition.cnn.com/2019/01/16/health/shutdown-fda-new-drug-approval/index.html
The FDA has five weeks till money runs out for approving new drugs. By Michael Nedelman, CNN:
‘The US Food and Drug Administration has roughly five weeks of funding left to review new drug applications during the shutdown, commissioner Dr. Scott Gottlieb said Monday on Twitter. Experts say this could have a ripple effect, bogging down the approval and manufacture of new drugs, delaying patients from getting these treatments and adding to a host of other crucial FDA actions and oversight that have taken a hit during the shutdown.’ Etc etc.
https://www.pharmamanufacturing.com/articles/2019/the-shutdown-and-the-fda-what-pharma-companies-need-to-know/
The Shutdown and the FDA: What Pharma Companies Need to Know In the process of working with the FDA? Exp
Expect delays. By Joel M. Wallace and Imron T. Aly, partne
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