If we have proofed on a large scale that the IGF-1 factor Is safe (the medIcInal part of the medIcal devIce that botched wIth the EMA CommItee), and we concluded an extended trial with a small but still reasonable 7% sample improvement compared to the placebo group, what prevent us to get a EU EMA approval as a Medical Device that support wound treatment in adjunct to standard care?
We cannot say that we promote wound healing (In Europe we have a much larger application spectrum than the USA), but we can say that the safe medical application support wound healing and assist in reducing patient wound pain. In the EU the standard of care changes substsantially among the EU ststes and anything that is considered safe can be considered good in tems of applications. Eventually, we do not have a superstar, but still is good and safe. Modesty is not good in medical terms?
Previously, we even had an EU inventory ready to be dispatched.
There are so many competItIve products that enter in the EU market just with very small improvements compared to the competition, so I do not understand which are the terms that leads management to not keep open the EU EMA application that was just previously suspended.
What is the cost at this stage to have the EU EMA application presented as completed and being approved?
Any product that Factor Therapeutics gets approved in any market leads to build a sort of addItIonal value to the comoany, and I believe that all shareholders at this stage would support any positive attitude compared to a full debacle.
In conclusion, we did not fail because the medical device is unsafe for the patients, but because we came out with results not so outstanding as everyone was expecting. But being safe, does not prevent us to keep us alive and gets value to exist with a range of safe tested medical device products that support wound healing and reduce pain with a bit cheaper solution compared to existing practice.
If we keep ourselves in existence, we can get better research solutions and applications for new products, if we say that all is over we die. With a bit of more modesty in objectives, we could be still one of the other small biotech company with at least one product in the market. Then is up to the people that we appoint to the management to compete in a very competitive world. But Europe is a large market and any open channel can have a corresponding good value. Once approved is a matter of the sales channel to get sales. In the past we appointed Quintales to follow sales on behalf of Tissue Therapies, so nothing new in this.
In the end the main topic is to have a solution that is safe, even if not so revolutionary as was always stated by this company.
FTT Price at posting:
0.2¢ Sentiment: Hold Disclosure: Held
