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It is not easy to get any FDA approval. Companies go bankrupt after spending millions and still don't get approved.
by mandeepj 8y ago
It is not easy to get any FDA approval. Companies go bankrupt after spending millions and still don't get approved.
- johnnyfaehell 8y agoWhen you have more money than the government that’s no so much of a problem.
- mandeepj 8y agoYes, Apple is excluded from that statement. The company which had a budget of $1 billion for their new headquarters and end up spending $5b :-)
- mpweiher 8y agoAnd have that still be a rounding error on their balance sheet. :-)
- masklinn 8y agoTechnically Apple has more money than some governments, it's nowhere near the US Government's: Apple's entire assets could pay for under 18 months of net interest on the public debt (263bn in 2017).
- tinus_hn 8y agoThe US has negative money, they are in debt. I have more money than the US.
- singularity2001 8y agoMaybe you can make an offer to buy the US with 30% of your net worth. Then resell to a hedge fond.
- tinus_hn 8y agoI don’t think I have the patience to deal with the ‘deal maker’ in chief, sorry. I’ve heard he’s got quite a lot of experience with bankruptcies though so he might have new ideas to deal with all that debt the US has been taking on lately.
- masklinn 8y agoThe US has assets to cover its debts in spades. Nobody would give them money for free if they didn't. And the debt is owned at ~50% by the government itself or the Fed and ~20% by various non-federal investors (pensions, mutual funds, local governments, individuals) with the rest being owned by various non-US entities.
- snowwrestler 8y agoThe U.S. federal government can accumulate only debt, it cannot accumulate savings. Why? Because any surplus it generates is stored in Treasury bonds, which are also counted as debt. Things are different for the federal government. It's an institution of last resort, so the normal ways of thinking about personal finance don't apply. It can't open a "savings account" anywhere, because every other institution on Earth is smaller and less reliable.
- yostrovs 8y agoIt's a 510k "clearance", not an "approval". It's relatively cheap and all you have to do is show your thing (ECG in this case) is effectively the same as other similar devices (older ECGs) for medical purposes.
- o_____________o 8y agoWas looking for this in the comments. The ambiguity there is abused by many companies on the fringes of consumer health and cosmetic products. > A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval
- deleted 8y ago[deleted]
- dominotw 8y agoDidn't theranos get FDA approval too.
- pkaye 8y agoThey have different types of approval based on the risks involved. Some are a lot easier to obtain.