Anyone would summise that some investors think researching / developing / trialing / registering and marketing a product WORLD-WIDE is childs play. Any investor in CST that believes this should never have invested in the first place.
The impatient (waiting for FDA approval and big profits)are bailing out and dragging the share price down.
FDA delays should be anticipated. Remember the "in tube" test is for automation type processing in the lab so requires a lot of repeat validation work to show interlab and intralab accuracy and precision and reproducability - I bet this is what is holding things up.
With this goes stacks and stacks of lab paperwork Standard Operating Procedure work, Analytical Lab Methods, Validation work etc etc from seeveral different labs. Add to this training procedures etc etc. All this from multiple labs. Cellestis is dependent on cooperation from multitudes of scientists in this scenario. Also FDA would be required to consult and inspect these labs to check their data.
This FDA approval is far tougher than the original submission.
The people at Cellestis have done a wonderfull job I think and loyal shareholders will be rewarded in due coarse. This stock has always been a long term project. Sales will grow exponentially over the next few years. The Mantoux test has been around for so long it is hard to break old habits. I will predict the Mantoux test will disappear altogether within 3 years and QFT will have a global monopoly.
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