Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
****************************/series/spotlight
You may have to cut and paste into address bar.
A must watch, as an aide-mémoire for current investors and those who are on the cusp of becoming investors: -
https://www.youtube.com/watch?v=uGkTJRpO4do Justin Waite
Published 21st July 2019
In this video he covers news from Nuformix #NFX in a summary format.
IMO, it really reinforces why judicious investors have invested their hard-earned cash and why others should do the same. Not only from a confident investment perspective, but also for altruistic reasons.
Hi Bailedintime you’re quite right in highlighting the more recent document (below) than the one I referenced: -
‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry’
https://www.fda.gov/media/109951/download
However, due to it stating the following: -
‘DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Contains Nonbinding Recommendations Draft — Not for Implementation’
I was unsure if it had been adopted and therefore, referenced the previously formal procedural document. I apologise if it has caused any confusion.
If certain individuals spent more time doing their research, other than continuously emitting negative and unfounded statements, they would realise that MTFB, may have most of the ‘bases covered’. See: -
https://www.fda.gov/media/72253/download
Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants
X. DOCUMENTATION OF MEETINGS......................................................................... 10
‘Before the end of the meeting, FDA attendees and the sponsor or applicant attendees should summarize the important discussion points, agreements, clarifications, and action items. Generally, the sponsor or applicant will be asked to present the summary to ensure that there is mutual understanding of meeting outcomes and actions. FDA staff can add or further clarify any important points not covered in the summary and these items can be added to the meeting minutes. The summary can be done at the end of the meeting or after the discussion of each question.’
IMO, MTFB are undertaking good practice and following due process. By seeking additional clarification from the FDA, one would hope resources are managed effectively and previous issues are resolved in a timely manner. However, patience is required as investors (myself included) are obviously extremely frustrated and irritated with the current state of play. Unfortunately, drug development is not a quick route to fiscal stability. But we should also not forget the humanitarian benefit to the patients, who are experiencing the consequences of a life-threatening ailment. They will also profit exponentially, when this gains approval.
Just to finish, I am totally in favour of Free Speech. However, certain individuals may want to research: - Defamation and Libellous!
Well posted Mars1.
Dan has previously mentioned; future collaborations will be based on individual company royalty assessments. These arrangements can not be underestimated, as the benefits could be humongous: -
Canada Pension Plan Investment Board acquires rights through subsidiary CPPIB Credit Europe S.à r.l. 20 May 2019 – LifeArc, a UK-based medical research charity, has received US$1.297 billion from CPPIB Credit Europe S.à r.l. – a wholly owned subsidiary of Canada Pension Plan Investment Board (CPPIB) – for a portion of its royalty interest in Keytruda
https://www.lifearc.org/lifearc-monetises-keytruda-royalty-interests-20052019/
in Artificial Intelligence (AI). Computational Biology Programme Lead Namshik Han was on the panel at #Impact18 earlier this month, discussing how artificial intelligence is reshaping biotechnology and healthcare sectors.
https://www.milner.cam.ac.uk/the-milner-institutes-namshik-han-takes-part-in-a-panel-discussion-at-impact18/
There continues to be, not only enormous potential profit for NFX investors. But the humanitarian benefit to the patients who experience the consequences of a life-threatening ailments, which sometimes becomes forgotten in the process.
Have a good W/E
TaffEvans I totally agree with your posts Re: Yes 09:42 & 09:46. I very rarely post but follow the regular share chat/discussions from both my own confident investment perspective and for altruistic reasons. My mum had cancer twice 37 & 22 years ago and thankfully, due to drug development at that time, is now a relative healthy 95 yrs old. It would have been fantastic if she could have had access to something like NXP001, to alleviate some of the horrendous side effects she experienced.
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. Although, in my opinion, at times there are some contributors (as previously highlighted by others) who are unaware of exactly what NFX has and its full potential. Perhaps they haven’t been proactive in doing their research.
Maybe they should listen to or listen again too, previous podcasts, especially yesterdays, where Justin comments. One of the keys points is NFX – ‘don’t have that very expensive long runway through, phase 1, 2 & 3’ studies, ‘all are self-funded’.
**************************************/articles/nuformix-bigdish-versarien-and-chris-bailey-ba61344/
I have taken the liberty of highlighting a few things below: -
Business plan: - Dan mentioned, this has not happened ‘by chance or accident’ stating they ‘started our company 10 years ago. Thereby, inferring, a lot of planning and hard graft has been happening behind the scenes to get where they are today.
Royalties: - Dan mentioned current arrangements with Newsummit Biopharma (NSB), Ebers etc and the benefits of these arrangements. Future collaborations will be based on individual company royalty assessments. These arrangements can not be underestimated.
Example: - Canada Pension Plan Investment Board acquires rights through subsidiary CPPIB Credit Europe S.à r.l. 20 May 2019 – LifeArc, a UK-based medical research charity, has received US$1.297 billion from CPPIB Credit Europe S.à r.l. – a wholly owned subsidiary of Canada Pension Plan Investment Board (CPPIB) – for a portion of its royalty interest in Keytruda
https://www.lifearc.org/lifearc-monetises-keytruda-royalty-interests-20052019/
By the way, NFX Dr David Tapolczy, Non-Executive Chairman was CEO of the above LifeArc a UK Charity (formerly known as Medical Research Technology), before joining NFX. Besides previously holding substantial positions at several significant organisations. Interesting during Dr David Tapolczay tenure he is involved in: -
MRC Technology (now LifeArc) licenses antibody to Newsummit Biopharma for development of Hepatitis C virus infection therapeutic
https://www.lifearc.org/mrc-technology-licenses-antibody-to-newsummit-biopharma-for-development-of-hepatitis-c-virus-infection-therapeutic/
Perhaps the most relevant disclosure Dan made (never heard him as animated!) was regarding the future company direction, and potential invo
‘As the government shutdown stretches on, pharmaceutical companies must manage the partial shutdown of the U.S. Food and Drug Administration (FDA). The longer the shutdown lasts, the more likely that FDA review of applications will be delayed, affecting company launch plans and business strategies.’ Etc etc.
However, perhaps we will never know. Although what we do know is, Iclaprim has achieved reassuring results.
www.ahdbonline.com/conference-correspondent/2641-pooled-analysis-of-patients-with-wound-infections-in-the-phase-3-revive-trials-comparing-iclaprim-with-vancomycin
Pooled Analysis of Patients with Wound Infections in the Phase 3 REVIVE Trials Comparing Iclaprim with Vancomycin;
‘As we know there are positive clinical study outcomes for iclaprim, which shows that it has achieved noninferiority to vancomycin in the subgroup of patients with wound infections i.e. Noninferiority of iclaprim v Vancomycin phase 3 trial’
Although, hopefully, we won’t have long to wait for the conclusion! Here’s to a positive result which will not only profit MTFB investors. But the humanitarian benefit to the patients who may experience such devastating consequences of a life-threatening ailment, which sometimes gets forgotten in the process.
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
Just to put the record straight, as unfortunately, over inflating any valuation/pricing ($66B) does little to inspire confidence and may discombobulate investors.
Current value: -
GW Pharmaceuticals Market Cap: 5.498B for May 15, 2019
https://ycharts.com/companies/GWPH/market_cap
However, this is still phenomenal growth over the last six years when it was $0.12B on 24/04/2013 and hopefully, NFX can replicate this prodigious achievement, but over a shorter time framework: -
GW Pharmaceuticals Market Cap 2013-2019
GWPH https://www.macrotrends.net/stocks/charts/GWPH/gw-pharmaceuticals/market-cap
If you would like to check the validity, please copy and paste the links into search engine!