Just some thoughts from my understanding of this...
Yes BARDA would be gold in terms of resulting in funding to complete clinical studies for US FDA approval. But, not receiving BARDA is not such a major (agree with Jev on this).
Getting Eurpoean approval (CE Mark certification) is a different kettle of fish, likely faster than a multicentre trial and cheaper so this is likely a better option if BARDA does not come through.
Also, the US market and the entire first world is comparably small market in burns as the major worldwide market for BTM in terms of volume (at a much lower price point) will be in the third world... hence there is potential for trials in countries outside the US to get the product to market. This is where Polynovo and Laurent have done well, they have a product that can have a long shelf life, is synthetic and inexpensive to manufacture (compared with collagen products like integra which is so expensive it is not an option for the majority of the third world)...
Hence... I remain positive for Polynovo to be cash flow positive in the first few months of next year from TNP dressings... then greener pastures on BTM.
As for Metabolic... I'm not sure enough has been announced for any shareholder to understand where DK is up to in terms of further studies or the marketing of AOD... but I remain hopeful that with the media it has received in Australia, the reported number of people taking it with no reported adverse effects, at a cost I understand to be quite high with low volume production... that we soon find out about further progress/plans... it seems to be there is too much knowledge of safety and evidence of efficacy to put it on ice or to sell it off!!
Gav
CZD Price at posting:
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