Relatively small delays like this happen often in business. Particularly when it comes to government processes.
In the broad scheme of things, it really is not a big deal if the waiver arrives in July or January, as long as it arrives (and i am of the opinion that it will arrive).
Given the current cash burn and the timeframe (ie US flu season) slippage this is pertinent to LDX and its current valuation.
Note that one of the supposed benefits of Doug coming on board as CEO of LDX was his vast expertise with the US regulatory side, yet he, and the market, was blindsided by the quick approval of FebriDx on their revised application and the 3 months, so far, slippage in the receipt of the PLA code.
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