The data is in the hands of the FDA for review.
For most , that is a big deal. SI has updated the market as demanded by many. Obviously this data has to be reviewed and the final potency assay and the parameters agreed too before the BLA is fully submitted.
So has the company met the optimistic expectations of holders. No, but how many companies can do that?
SI was hoping to be able to inform the market that the BLA had been submitted. If he had made this a reality investors would still have been unsure of wether the data and potency assay was acceptable to the FDA for up to 6 months. This way however we will know much sooner. Any were between 1 day and 3 months.
So in my opinion this announcement actually is better than many anticipated.
Good luck all.
The data is in the hands of the FDA for review. For most , that...
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