The basic conclusion is that more trials are needed and SAWP needs to tell them what those trials are since they are so far along the process and they want to do the minimum.
That will cost "money" or "equity."
The company doesnt have the money to run, operate and conduct a trial for 12 months - even the most basic of trials therefore they need to raise funds somehow..
and it is going to be at least a year before this gets sorted out (I am not sure if they submit in a year - do they start a new assessment process with all of the 210 days that go with it).
In terms of their Q and A
The Company presented a matched patient cross-trial comparison using data from a large standard care population in the UK, that showed a major significant difference for healing in favour of VitroGro ECM over 90 days. That data was also extrapolated to 365 days and assuming patients remained in the clinical setting. Using a conservative forecast, the data showed that benefits are likely to continue after VitroGro treatment, provided patients remain in standard care in a clinical setting.
This is very dodgy - I am not sure what data you can extrapolate meaningfully. Just because a wound heals by 30% - you cannot assume complete healing over time !
TIS Price at posting:
10.5¢ Sentiment: Sell Disclosure: Held
