>>So exactly why would a JNJ or Baxter want to do a JV with Arch after CE mark obtained in 2016? Wait for 2018?
A partnership ahead of US trials will aid in creating the least arduous pathway, especially since the FDA likes to see assurances of consistency in product and rapid access to market. A BP partnership gives assurances for what the FDA likes to see.
>>Arch "Only" has to spend $ 6 to $10 million to get FULL US and Europe approvals. That is it. This is medical device so tests are relatively quick.
Do we know the FDA will agree that AC5 is a device? If it is topically a device, would the FDA also allow it to be classified as a device for internal use? A BP partner can more easily argue and convince pre-IND and INDA reviewers that it is still a device.
There are huge advantages to a BP partnership that goes way beyond the cost of trials. Without a partner US trials can easily slip from 2018 to 2020 and later.
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