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Re: Bad day for MO - reasons?My understanding of this is parallel to your post. PM/MO is likely to ultimately get approval to market IQOS. That should happen before years end. MO probably won't actually bring IQOS to market in 2017, but it will probably be permitted to. Note that if the FDA denies MO's ability to market IQOS, its probably not going to permit any OTHER vapor/heat not burn product, either. Because of still not addressed "deeming" restriction, this would effectively permanently ban all HNB and liquid based vape products from the US marketplace. That ban, in turn could potentially spark a serious backlash (FDA bans "safer nicotine products"). To market IQOS as a reduced risk product requires a completely different track. The FDA has a policy in place its supposed to follow to evaluate PM's application, and that policy specifies an initial review of the application followed by a formal six month evaluation period, but as per last post, there is LITERALLY a ton of documents that need to be reviewed first. More important, so far as I know PM is the first to EVER apply for this FDA review process for ANY tobacco/nicotine product. So not only is the evaluation process itself utterly untested, any approval (or rejection) of the application itself will be unprecedented. These things alone are likely to cause the FDA to move slower than it otherwise "could". Even if the FDA wanted to give this some sort of expedited review process (which it probably doesn't) I'm skeptical that it could pull it off. I honestly don't think the FDA is going to deliberately stonewall this (though it could) but I'd actually be shocked if the FDA put out a definite yes or no decision in only 6 months.
I agree the FDA could take potentially take years, but at SOME point its going to have to reach a decision. At a fundamental level, this evaluation shouldn't be all that different than evaluating any other drug or medical product, and the FDA does that all the time. But this is more politically charged, and as above, unprecedented, so FDA is probably going to move slowly. Also, PM/MO aren't entirely without resources or political allies. If the foot dragging is REALLY prolonged, at some point they could try to put some external pressure onto the FDA to either make a decision or at the very least to explain where in the process it is, and how it expects to make progress. But yes, I could easily see this taking over a year, and even two. In the meantime, PM/MO would be barred from making marketing-related reduced risk claims on this product in the USA. PM may be able to make certain claims OUTSIDE the USA. Obviously, MO can't market directly with those claims, but there is some significant medical study indicating relative health benefit of heat-not-burn (vs conventional smoking) that might make lay press, physicians would learn of it, etc. Lastly, with much competition brewing, and potential for significant "first into market" advantage, MO can't afford to wait forever before introducing this product. I'd imagine it ALREADY has a plan on what to do if the FDA drags its feet. In fact "Plan A" probably assumes that the product will be marketable without MO having the the ability to make RR claims. MO would then have a tentative rollout date (perhaps Q1 2018) and have a marketing plan for that type of rollout in place. It would also have a contingency marketing plan "B" that could be rolled out at any time if the FDA were to approve RR status. Plan "C" would be quick approval by the FDA of RR status, with associated rollout. |
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