Дело тут непростое. Вкратце:
PDUFA date was 1/15 but FDA missed one the the 3-d party plants which will be making insulin for them. So fda has to inspect it and it has been 2 months, no one knows when that will happen. Originally management thought 2-4 weeks but did not happen. FDA not giving dates but seems very comfortable with the drug even before approval - they asked the company to extend the age of the upcoming juvenile drug trial from 8-14 years old to 4-14 years old. which I think is a huge sign. The inhaler they have now is good but they came up with a new design and decided not to bring the drug to market with the old ihnaler - they will wait till the new one is produced and approved. So really they will not start selling till q4 of this year. But if the drug is approved they are looking at 1-2 billion/year sales only in US. Speculation is - they have proposals from european partners waiting for an approval to step in. Analysts say that with approval and a partner stock can run to 30-50 right away. From $10 even the low end is 200% gain




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