| | | Welcome to SI Biotech! But this isn't really the right board for this topic. The best place to ask is the "Biotech Valuation" board.
I took a quick look at AQST wrt to this FDA decision. I haven't pored through the trials; I'm taking their statement that they've demonstrated bioequivalence at face value. And assuming they haven't seen any safety signals one wouldn't normally see with Clobazam. That said, I wonder if the FDA is really the gatekeeper for this product. I'm thinking it would be insurers paying for it or not. LGS patients do seem to have more dysphagia than standard epilepsy patients, so I can see some theoretical rationale for it, but whether or not that's enough for insurers, I don't know. It's a rare form of epilepsy, so it's not like the market is big (most epileptics don't have dysphagia to the extent that LGS patients do, so I genuinely doubt insurers would cover that, much larger, market).
AQST has a broad pipeline of slight improvements (from an insurers perspective), so I don't know that it will ever move violently except when insurers do something regarding one of their products, especially ones that are wholly owned and going after big markets.
If you're going to follow the company I think you should a) see if they mention insurance/formulary issues in webcasts (but none are archived right now), and b) actually call the company and ask. Try for Mr. Marshall, the commercial officer; settle for just investor relations if you have to. Have your questions prepared. Some young companies are pretty open to us regular folks talking to upper management if we don't waste their time flailing around in our communications. If they have nothing to say, tell them you're disappointed, because it's of importance to potential investors. If they are a few months from launch, they should have been talking to insurers by now. If not, red flag.
Here's the link to the Biotech Valuation board. Biotech Valuation
Cheers, Tuck |
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