Hi Gem, a simple is yes, I do – the potential implications of any Andrews/FDA study are too big to ignore...
We know stem cells work in theory and we know that SVFCs method produces more of them; the INDs is around combining both of these facts to prove that treatment with cells prepared in the SVFC manner dramatically increase recovery/repair in the body (when compared to other extraction methods). This pre-IND with Andrews is about proving the safety and efficacy of the SVFC extraction method and if we can get them classed as minimally manipulated then so much the better.
I believe that the definitions given in the FDA guidance leaflet from December 2014 could be challenged – they talk about manipulating adipose tissues and cells – why worry about changing the adipose cells when you’re going to dump them anyway, much better that the regulations confirm that any cells to be reintroduced to the body are minimally manipulated. This slight change makes a MASSIVE difference to the SVFC process and allows this extraction method to be used to generate income from other research bodies. If the ultrasound container adds to the argument and helps gain the support of the FDA, again a small price to pay. This isn't a big deal for me but it does show progression and a willingness to work with the FDA.
If we don’t get minimal manipulation confirmed, it’s no big deal, just means the studies will take longer but once the first study proves safety etc, the number of INDs that can start are unlimited and we already know about gum recession, cardiac, diabetes, neurology/stroke/ALS and the list goes on. Don’t lose sight of the impact that an IND on ALS could generate, there is NO known cure for this condition and here we have a treatment which slows down the progression of the illness – how much interest could that generate in terms of lobbying to rush trials through, who knows, maybe even on Capitol Hill.
I haven’t forgotten the international option, SVFC already has some international patents and could be exploiting them more but things seems to be hanging on the decisions of the European patent application and having read the revised submissions, I think there’s a strong case for the patent to be granted which changes things again and opens up the European market.
I think we have a ‘perfect storm’ combination here, a number of BIG decisions are coming and could happen in a short space of time which will have a monumental impact on the technology, funding, IND proliferation etc and ultimately shareholder value etc.
Each decision on it’s own could impact SVFC but the combination could create a mega tsunami rather than a number of ripples in a pond if you get my meaning.
Yes, some of this is speculation, perhaps wishful thinking but this is too important to write off as a scam as there’s too much evidence to the contrary.
