2Mês·

Exception 503A- loophole

$HIMS (-15,45%)

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For those who did not know it yet:


Some drugs, like GLP-1 (for diabetes and weight loss), are very popular but are tightly controlled by the FDA to ensure their safety and high quality.

However, there is a loophole in the law called the 503A exemption, which allows pharmacies to make customized versions of these drugs for individual patients on a doctor's prescription. This means that companies like $HIMS (-15,45%) could potentially sell these drugs without having to go through the usual rigorous FDA approval process.

If they do this, it could be a smart way to meet the huge demand for these treatments.


$HIMS (-15,45%) is now promoting personalized GLP-1 because it allows them to avoid the shortage regulations.


As long as a doctor prescribes a personalized prescription that is not available on the market, that prescription can be sold whether there is a shortage or not. (503A)

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11 Comentários

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2Mês
Until the gap is closed at the instigation of the competition lobby. That happens very quickly...
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@Epi Isn't the new health minister good with hims
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@Epi But I don't think this will happen any time soon, and certainly not under Trump. They want to offer overweight Americans a cheaper solution that is accessible to many people who cannot afford the expensive product $LLY. It also creates competition. Apart from that, it is currently only a minor revenue stream for $HIMS and not the driver of their success.

But of course it can't be ruled out, but as this is a general regulation and not just this product variation, I don't think it will happen as it would be detrimental to the consumer and they want to make access more affordable for the American.
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2Mês
@Lumimyrsky Maybe. With the profile of Trump's people, I wouldn't count on anything. 😅
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@Epi also true
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Are you sure that's the case? I've read something on X before, but then it wouldn't matter what's on the shortage list and what's not. Somehow I can't quite believe it 😅
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@Leipziger_Jung Yes, I am, but it has to be prescribed and cannot be dispensed on a whim. There are just a lot of very overweight Americans who couldn't afford a dose of 2,000 dollars. If you go there with 60 kilos and say you want the medication so that you have 50 kilos, it won't work 😁. But we'll see how that works in practice.
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@BamBamInvest let's see
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@Leipziger_Jung Right, apart from that, the share of sales is still very low, so it can only be a potential lever 😁
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@BamBamInvest yup, that's right. I've always found it inappropriate in the past when people write off HIMS just because they may no longer be allowed to offer GLPs. But the growth potential in this sector is huge, so I hope you're right.
If they are allowed to continue to sell the prescription syringes - plus offer Liraglutide, where the patent expires - then I see something between 2.5 and 3 billion dollars in sales this year.
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@Leipziger_Jung Let's hope so, I think $HIMS will give us a lot of pleasure in the future.
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