no biotech company is ever going to have a "smooth" approval process - note that even the giants in the field are feeling that right now!
Is that a reason to ditch? Why the blazes did you get into a biotech stock - knowing that that will always be the case and no matter how good your product may be there will never be a guaranteed outcome.
on a side-note: I took yesterday to get into PXS - like BTA one has to take a punt and a low point is sometimes a good time to enter
Look at what the BARDA grant has done to BTA : close to nothing despite having resolved funding issues to complete PH II + III trials !!!!!!
drug approval bodies, page-3
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