While "fingers crossed" is not a good investment strategy, with biotech its all too common. So I'm crossing mine anyway. I'm a big fan of the long term prospects of this stock, but it sure would be nice to get to some all time highs quickly, post clearance.
The final approval considers many requirements - from drug safety, efficacy, manufacturing, packaging ....
The companies need to be careful in submitting all right paperwork else you get CRL. The CRL does not mean new trial but adds at least 6 months of delay in approval. That becomes a bad news.
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