Ann: Lancet Publication Demonstrates Superiority of PSMA Imaging, page-2

So two interesting anns today.

The Merck ann is interesting if vague. I couldn't help but feel (maybe a bit cynically) that the line about reporting obligations was put in to (a) cover for the lack of detail and (b) play peek-a-boo a bit.

Why is the Merck ann interesting? Because every bio loves to go on about how interested Big Pharma are in them. I've learned to switch off whenever a company says that unless they can provide some definite piece of evidence that it's true. So count this as evidence.

This Lancet article is interesting for several reasons. First of all it indirectly links back to the question of reimbursement rates: the article compares illumet with Axumin, which gets US$3000 reimbursement and is clearly in Telix's sights. It also supports the hypothesis that the FDA might look positively on the NDA application

Secondly, and I didn't notice until I reread it, it mentions that the pre-NDA FDA meeting has happened (27th Jul). This is a bit late (it was promised for Q2) but that may well be a matter of fitting in with the FDA. Getting FDA bookings seems to be a slow process. However based on the last FDA Phase III ann (Jun 17th meeting, Jul 15th ann) we can anticipate the ann for this  coming out in about a month

Thirdly, it's an article in Lancet Oncology. Now I don't want to sound like a journal snob, but this is a big deal. This journal has a very high impact factor and as their own webpage puts it is in the top three of 200 odd oncology journals. Again this compares with a lot of other bios who will breathlessly tell you about the poster they've presented at some conference or the journal article that comes out three years after the ASX ann in the Journal Of We Promise You This Has High Impact Even Though You've Never Heard Of It. So again this lends weight that there's a good chance the FDA will approve it because It's Much Better Than What's Out There is a damn good reason.

I can't remember if it was Telix or Chris B, but one of the two has a snapshot of the key pieces of info from the Lancet paper on their twitter feed (enough to be informatice but not enough to get them into copyright trouble.) It's worth keeping an eye on these two twitter feeds. While they don't (of course) tell you anything the market doesn't already know, they're still useful for "the vibe".

Summary version: while FDA approval is never a fait accomplit, this looks about as close as it gets. While reimbursement rates are never guaranteed, this looks about as close as it gets. While a Big Pharma takeover is never guaranteed, there's now evidence that shows the possibility isn't a fantasy.