Cobus Loots, CEO of Pan African Resources, on delivering sector-leading returns for shareholders. Watch the video here.
@bald_eagle, there are many medicines which are being sold OTC and no one knows how they really work. But what we know is they are safe and they work. And some of them are found accidentally. One best example minoxidil - its market size 1077.81 Million USD By The End Of 2025. Durg which being worked out for heart related issues is working for controlling baldness.
However, according to a 2012 amendment of section 513(f)2 of the Federal Food, Drug, and Cosmetic Act, device manufacturers can apply for a de novo classification for a low- to moderate-risk device without submitting a 510(k).
For people who wanted to understand the application process and technical details about - De Novo Classification. IMHO, it looks exremely promising and quicker route.
As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an alternative means of classifying low- to moderate-risk devices. Traditionally, these devices were automatically classified as class III devices after the Food and Drug Administration determined that they are not substantially equivalent during review of a 510(k) application.
However, according to a 2012 amendment of section 513(f)2 of the Federal Food, Drug, and Cosmetic Act, device manufacturers can apply for a de novo classification for a low- to moderate-risk device without submitting a 510(k).
https://www.thefdagroup.com/blog/2015/08/what-is-a-de-novo-classification/
Futura Medical CEO talks regulatory timeline and commercial potential for breakthrough gel
https://www.youtube.com/watch?v=-ilHI1j-QOw
@BCB, I doubt about extremely positive news. It would be probably positive news or reiteration of earlier +ve news about Dermasys working with more some scientific details. The stock is under-valued.
@frankmu, about your comment - news about TPR are due by the end of the month. I don't think RNS would be issued for that. I might be wrong. They may have already submitted the lab work to the regulatory. Same thing happened with other Pharma compancy recently (Faron). They had something going with FDA and RNS was not issued.
@Italian, some of them can be investigated and charged for market abuse. The kind of infomration the cater is rubbish and misleading. They don't check the RNSs, don't believe in experts in the field and don't even know how to find scinetific information. Irrespective of weather Futura succeeds or not, the factual information is out there. When we rebut with factual information, they simply ignore and don't reply. When there is dip in the share price, they rush here with their scaremongering devious assertions.
@PATTSV, since they are going devive route which doesn't have chemical action, chances of FDA requiring another trail are slim. The only concern we heard from KJ is that FDA doesn't want the efficacy of the ED treament concealing the underlying health issues such as heart prolbem and etc. They may advise the same instructions that have been advised for other ED treatments already available.
Serious investors go by the RNS and the hard data. You guys ridicule the mirror article and use the same article to carry on with devious assertions.
My suggestion / opinion
- read the RNS
- read the data
- listen to the experts in the field
- don't spread the lies like Ralph talking positive because he is being paid.
- finally close your shorts to save money.