Futura Medical Share Discussion Threads

[lbo] 02/12/2022 17:33

https://www.lexology.com/library/detail.aspx?g=6dc83ac3-d242-41a8-86c2-93e5dc6bccb61. CE marking does not in itself constitute evidence for medical efficacy claims. Advertisers still need to ensure that they hold adequate evidence for claims.Why this matters:This ruling highlights that CE marking does not constitute evidence of medical efficacy and that it is important to refer to current NHS and government guidance when making health claims. In addition, the ruling is a reminder of the need for businesses to ensure that all health claims should be fully substantiated so that consumers are not mislead on the product's benefits and abilities. In particular, businesses should ensure that any tests are conducted with clear methodology and relevant test participants (reflective of the target audience).

[petroc] 02/12/2022 17:28

From Proactive Investors: 'Futura Medical PLC (AIM:FUM, OTC:FAMDF) looks financially well set for the commercial phase of the journey of its lead product, MED3000 for erectile dysfunction.

Interim results for the group showed it had £6.68mln in the bank as of June 30, 2022, the period's end, with a further £910,000 in research and development tax credits set for payment in the second half.

This, it said, provided it with resources beyond the initial product launches of MED3000 and its expected US regulatory approval.

Branded Eroxon, the fast-acting gel has European regulatory clearance and, in August, received ‘highly positive resultsâ€͐2; from its US phase III trial.

The company will file the data packages required by the US Food & Drug Administration later this month with the aim of approval in the first quarter of next year as the only ED treatment available over the counter in the States.

Eroxon will compete with existing blue pills on the speed of onset and will be targeted at men who have suffered side effects from using products such as Viagra and Cialis.

Plans are advanced for its launch in the first half of next year. Futura has a licensing agreement with Cooper Consumer Health for the rights to commercialise the gel throughout the European Economic Area, the United Kingdom and Switzerland.'

[lbo] 02/12/2022 17:24

Perrigo's Evidence For Nasal Spray Claims Not Enough For ASA





Assessment

Upheld

The ASA acknowledged that the product had been CE-marked as a class IIa medical device. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held adequate evidence for such claims.

it was not clear from the methodology used in the study how participants had been randomly assigned to their respective groups. We noted that it was not peer-reviewed and not published in a mainstream scientific journal. For those reasons we considered that the trial did not provide adequate evidence to support the advertising claim.

Participants were also not blinded to their treatment.

because there were limitations to the study design, we considered it was not sufficient to support the advertising claim.

[petroc] 02/12/2022 16:51

'There are a few who just enjoy stirring the pot, but usually, if a person sells their position in a stock, they leave any chats or forums where that stock is the main topic of discussion. Why wouldn't they? Who wants to sit and talk about a stock they are no longer invested in? A basher, that's who.'

And guess who comments on this board (a lot!) and is no longer invested? LiarBO sold his stock in FUM FIVE YEARS AGO!!!

hxxps://toughnickel.com/personal-finance/Investors-Hub-iHub-OTC-Boards-Are-A-Bashers-Paradise

[lbo] 02/12/2022 13:24

Not the first time rampers have jumped on a similar bandwagon that failed to meet the rampers pie in the sky expectation! LOL









Aytu acquires Innovus in cash & stock transaction making a total deal value up to $24M

[petroc] 02/12/2022 12:17

LiarBO says 'How many times have you repeatedly posted the same misleading post now?' Guffaw! If that's not the richest question I've seen in a long time! No point asking LiarBO the same thing though, I already know the answer - five years!

[broomrigg] 02/12/2022 10:50

More good sized buys coming in again this morning :-)

[lbo] 02/12/2022 10:29

How many times have you repeatedly posted the same misleading post now?



5. They post their predictions over and over and over desperately hoping to move the market. They never do


Oral PDE5i drugs are the proven safe, effective and recommended first line therapy for ED. According to people and organisations who are qualified to make those recommendations.

You have also deliberately and repeatedly misrepresented the side effects and risks of the recommended first line therapy. It has many years of objective data in millions of users supporting why it is still the recommended first line therapy. Unlike Med3000 which has no non deficient data supporting its efficacy and very little and very short term safety data only in a very few number of users.



A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra.



Its all in the American Urological Association [AUA] guidelinesâ’

The therapies have not been validated’

˜I recommend what we have as standard of care, which includes pills, injections, penile prosthesis, and vacuum devices that we know work. Other therapies have not been included in the standard of care yet’

The first line therapy recommended in the General practice guidelines on ED is oral PDE5I drugs. Which would be based on all the available objective evidence. It would not be based solely on a rampers subjective and unqualified personal view. Or if a person just own shares in a company with a placebo gel alternative and who may have a vested interest and biased opinion.



First-line therapy

For most men with ongoing confirmed ED, first-line treatment will be a phosphodiesterase-5 inhibitor (PDE5I).



Phosphodiesterase 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are recommended as first-line therapy. With established safety profiles, these drugs are well tolerated and effective

GPC prescribing lead Dr Andrew Green:

'There is no doubt that sildenafil is a safe and effective drug’