Gotta chuckle....a lot of the indignant rebuttal is predicated...

Gotta chuckle....a lot of the indignant rebuttal is predicated on the 'language used in the announcement.' Language is a positive spin leading into a SPP......would you express a 'negative spin' leading into a SPP ? The other point is 'language VS reality.....' FDA is 45% funded by big pharma.......FDA directors who ultimately crunch the progress of amazing science that is generated by foreign companies are rewarded by well paid positions on their various boards or given leading positions in their research departments. The FDA narrative is rarely a flat out 'no...' it's a 'not yet....' we just need more data. The trials are highly expensive and require extensive fund raising. This process could take years & years. Two prominent examples are MSB & MVP. MVP market 'the green whistle.' The product is widely used in ambulances & sporting codes here, NZ, Europe, England & Singapore. FDA response........place it under a 'Clinical HOLD. Research the MSB experience yourselves but just take heed....buyer beware.....don't assume FDA is your friend !