FDA normal timeline for response to HDE application is 75 days from date of submission. So if we assume document submitted in mid October then we should have some response by April 2022... IMO.
My worry is more about not able to sell a single device in EU even after getting authority approvals for more then a year now... IMO.
There is something company is not telling all of us now... similar to how they simply withdrawn application after keeping all waiting for a year from TGA... IMO.
Other biotechnology companies normally issue asx announcement as soon as they receive query from FDA or as soon as they submit response to FDA but OSL has failed to do that again and again.... IMO... but ASIC and ASX love's to sleep... !
it will be interesting to see cash burn over last quarter and how much left now .... before CR is announced ... IMO.
FDA normal timeline for response to HDE application is 75 days...
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