SPL 3.85% 12.5¢ starpharma holdings limited

FDA meeting

  1. 4,801 Posts.
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    I think it is wrong to say mgt are guessing Stockrock that is why they will be paying big bucks for ex FDA consultants who will give them well educated or well informed “hopefully”reasons. A detailed plan to get best possible outcome will ensure the company does not walk away with a “start again” outcome. I was an exec for US international giant till retirement and have some knowledge of US regulatory bodies although not FDA, I would not underestimate the assistance of such consultants I expect their success rate is high for a bunch of reasons you can guess at. I am confident mgt will get some sort of approval to start selling in the US albeit with some caveats on more prevention data or wording changes on stated claim a s the word “may” might come into play. Remember FDA have stated no safety or manufacturing problems that makes a huge difference so I hold on bravely with some confidence of a at least reasonably positive outcome.
 
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