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Re: None

Wednesday, 08/12/2020 3:57:30 PM

Wednesday, August 12, 2020 3:57:30 PM

Post# of 27409
A positive note on a down day....

Remember the company has Breakthrough Designation for the removal of ticagrelor so this gives them the opportunity to interact with the FDA's experts in a more expedited and efficient manner, as well as receive feedback from the FDA . Under this designation we can also expect prioritized review of the submission at that point in time.

An interesting article on the Real Value of a Breakthrough Designation:
https://seekingalpha.com/article/4314267-real-value-of-breakthrough-therapy-designation

- Average approval time reduced by 2.5-3.5 years.
- Breakthrough therapy designation usually increases valuation significantly.
- Takeover offers typically increase with breakthrough therapy designations.
- Takeover offers for a company with 2 breakthrough therapy designations increase significantly and quickly.


If the REMOVE data comes back compelling, this could be the 2nd Breakthrough Designation for the company should they decide to pursue it.
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