The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Yep, I have tried the product and worked for me but I don't like the flood of bad reviews. Bad reviews put me off always but this time I made an exception given I wanted to try it out for investment purposes. Hence, I believe there might be a % of users who become loyal buyers but the market is not as big as it could have been with better market reception
I think due to uncertainty about the cost of the confirmatory study plus overall market sentiment.
I was reading again about De Novo applications to the FDA, it seems the FDA is happy with that route for this product, meaning it won't need a prescription (De Novo are for medical devices with low to moderate risk) so that's very good news. I'm pretty much expecting no action until September and some consolidation about 13? 12? I don't know. Then come September, if the confirmatory study is an small one (= cheap) share to jump, or otherwise drift lower as the company might need ro raise funds. I'm looking forward to that next RNS. No action until September unless there are news from the European Medicine Agency before
Not an expert in medical patents, but patents AFAIK must adhere to same principles, so in the case you are asking the competitor would have to prove their formulation constitutes enough "inventive step" over FUM's patent, slight changes around the same formulation wouldn't cut it, IMHO
You are answering your own question, you pasted 'Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application'
So they are not trying to sex-up anything, that's how patents work: you find a new application of your IP, you file for a new patent
where did they say "clinically insufficient"? can't find that text string in the RNS. Confirmatory Studies have become a usual request over the last few years. It's true FUM took late to realise DermaSys (~MED3000) is the product itself, without the need to add any Glyceryl Trinitrate (GTN) . This appears to have been a discovery accident, but can't blame them, Viagra was discovered by accident too
So the "placebo" that turned out to have a medical effect not explainable by the placebo effect, that is an opportunity. If the confirmatory study... confirms it has efficacy, then they are sitting on a goldmine
Didn't it go from 9p to 24p in a matter of days? some retrace was expected. The rest is probably due to the need for a confirmatory study the FDA has requested, that is going to cost some money (yet to see how many number of params, number of subjects the CS will have) IIRC, one of the reports from the company said that >70% of people in previous trials wanted to keep using the product so maybe the company doesn't even have to find new study subjects but just to recruit out of that pool.
So in short, uncertainty about that. On the other hand, the EU approval, assuming no similar request, could land before that study is even finished.
Confirmatory studies need usually around 10 participants per variable, question is how many, since safety of the product has been stablished in P1, P2 and P3, that won't be a thing a FDA would ask for, I think they'll want to confirm efficacy of the product itself. Regulations are very different between US and EU, I know that from my experience in other fields, EU approval could happen sooner than US if there's no need for such study on this side of the Ocean
Baldie, you wrote the following a few days ago:
"""
I volunteered to self-exclude myself from this echo chamber. I did briefly return but was grievously insulted...I asked for an apology..when none was given ( a missed opportunity by my detractors) it was tacitly agreed by all concerned that you would be entitled to the full on 100% bald_Eagle no holds barred experiential treatment...I have endeavoured to keep my end of the agreement. So help me god.
"""
That's why you keep wasting your time here
Confirmatory studies are much smaller than Phase III, their name is just a clue. Safety has been stablished in PIII, FDA will probably want to "confirm" one or two variables, I'm guessing that it actually helps ED patients. Smaller cohort of users, simpler study, smaller costs
You are not invested in this company, only employ your time to talk it down for personal reasons, I remember reading you are here because you have a personal enmity to some of the users who are invested?. Are you shorting the share at least?