I would hope/dream that there are 2 issues important at play.
1. That yes it would be knowledgeable to know that the addition of the Igf-1 is an advantage over not having it attached to the protein. That this can be determined in a laboratory situation with tissue culture to determine any advantage or not. That I'm sure already would have been done somewhere along the line.
2. The safety aspect. Which I'm sure is the most important. It may have been a less than perfectly designed trial, however the product materials have been used on many humans on many occasions already. As far as we know there have been no adverse effects on any of the patients. Surely that must go somewhere in allaying the fears about its use.
These approvals etc. are supposed to be based on a risk/benefit basis. Nothing is without risk absolutely, not even panadol, but its risk/benefit profile is acceptable. Regardless of the shoddiness of the design of the trials if Vitrogro has showed no detrimental effects, and actually considerable benefits in wound healing and pain management then I would think that the risk/benefit profile is quite compelling for an approval.
I don't know, but suspect there is a mechanism in the system for conditional approval with the understanding there are further studies.
What was the fate of all these trial recipients over the past 5 years? What was the general average fate of similarly wound carriers? How many amputees? How many deaths?
I wonder if there has to be a total capitulation to the EMA or a practical discussion. It would take a person with superior negotiating skills, which I am not sure we have in the company.
Many people have studied the EMA and it operational parameters over the past couple of years. Perhaps some knowledgeable insights into their flexibility would be of interest.
I absolutely shudder at the amount of highly educated people involved with this company, the experts, consultants and experienced persons who have been paid so much and have got it all so fundamentally wrong. I personally didn't believe it possible for the company to have got it so wrong, and I have been a consistent critic.
Those that have either jumped or were pushed from the company have a very dark stain for the remainder of their careers. Those that are still there I hope will know they are currently in the same shadow, and I hope they will work like they should, without inducements of options to get out of bed and do the work they are/have been paid handsomely already to do so.
TIS Price at posting:
10.5¢ Sentiment: Hold Disclosure: Held
