The ITCA 650 device. Photo: Intarcia Therapeutics

The FDA yesterday erected a new speed-bump for Intarcia Therapeutics, the Boston biotech "unicorn" that has developed a matchstick-sized implantable device for Type II diabetes treatment.

What happened: The FDA sent a Complete Response Letter that Intarcia says relates to aspects of its device manufacturing process (the letter itself was not publicly released). That means commercialization in the U.S. will be delayed from Q4 of this year to the second half of 2018. Intarcia says the CRL should not necessitate any additional clinical trials.

Why it matters, beyond for Type II diabetes patients: Intarcia CEO Kurt Graves has been the rare VC-backed biotech CEO who has insisted on commercializing before IPO, and yesterday told Axios that there is no change to that strategy. He added that the company has now raised over $615 million for its Series EE funding, which held a $215 million first close last fall at a $3.5 billion pre-money valuation. Most of the additional cash has come from sovereign wealth funds.

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Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9:45 p.m. ET: 19,282,972 — Total deaths: 718,851 — Total recoveries — 11,671,491Map.
  2. U.S.: Total confirmed cases as of 9:45 p.m. ET: 4,937,441 — Total deaths: 161,248 — Total recoveries: 1,623,870 — Total tests: 60,415,558Map.
  3. Politics: Trump says he's prepared to sign executive orders on coronavirus aid.
  4. Education: Cuomo says all New York schools can reopen for in-person learning.
  5. Public health: Surgeon general urges flu shots to prevent "double whammy" with coronavirus — Massachusetts pauses reopening after uptick in coronavirus cases.
  6. World: Africa records over 1 million coronavirus cases — Gates Foundation puts $150 million behind coronavirus vaccine production.

Warren and Clinton to speak on same night of Democratic convention

(Photos: Abdulhamid Hosbas/Anadolu Agency via Getty Images, Sean Rayford/Getty Images)

Sen. Elizabeth Warren and Hillary Clinton both are slated to speak on the Wednesday of the Democratic convention — Aug. 19 — four sources familiar with the planning told Axios.

Why it matters: That's the same night Joe Biden's running mate (to be revealed next week) will address the nation. Clinton and Warren represent two of the most influential wise-women of Democratic politics with the potential to turn out millions of establishment and progressive voters in November.

Trump considering order on pre-existing condition protections, which already exist

Photo: Jim Watson/AFP via Getty Images

President Trump announced on Friday he will pursue an executive order requiring insurance companies to cover pre-existing conditions, something that is already law.

Why it matters: The Affordable Care Act already requires insurers to cover pre-existing conditions. The Trump administration is currently arguing in a case before the Supreme Court to strike down that very law — including its pre-existing condition protections.