I'm not happy about the shelf and the overhang it creates for the stock price but I understand the timing. With the US NDA now filed and the EU filing imminent they're about to commence serious negotiations on an ex-US (and ex-Japan) partnership, and perhaps to listen to overtures for a US partnership or a buyout. To maximize their bargaining power in any partnership or buyout negotiation they have to show they can go it alone if necessary. Having enough cash to last into early 2017 as they currently do doesn't accomplish that. Now they can say they can raise more money IF AND WHEN THEY WANT TO. If they close an ex-US deal on terms that bring in a lot of upfront cash they probably won't draw on the shelf anytime soon, except perhaps opportunistically if the pps rises substantially. If after approval it becomes clear that they really are going to go it alone in the US they'll probably do a raise but we always knew that would happen.
I'll try to explain as best I can. If the original supplier had passed re-inspection ARLZ would probably have qualified for a 2-month review period, meaning the FDA could have acted any time on or before May 14. But because ARLZ brought in a new supplier the review period is 6 months meaning the FDA can act on or before September 14. But as I understood Adams it won't act before May 14 because that would mean it acted within a two-month time frame that doesn't apply. The main point is that Adams confirmed that although the PDUFA date is September 14 approval could come sooner.
Adams mentioned in both calls that while the PDUFA date is September 14, and ARLZ is acting on the assumption that approval will come then, it could come sooner and ARLZ will be prepared to launch. He said in the Bloom Burton call that it could come between 2 months and 6 months from the date of the NDA submission, which was March 14. Presumably it can't come earlier than the 2-month date because the revision of the NDA to substitute a new aspirin supplier meant that the review period would be 6 months rather than 2 months. So approval could come any time after 2 months following March 14, i.e., any time after May 14.
FDA waits until the PDUFA most of the time but it's not unusual for it to act sooner. I've seen it happen for cancer drugs (having trouble remembering the company names), but it also happened for a mfg issue for a specialty pharma whose symbol is FLML a couple of years ago (someone posted that on the POZN board at the time, and it checked out). The reason to think it could happen here is that FDA already reviewed the clinical data two years ago and had no issues, so if it's now signed off on the mfg facility there may not be anything holding up approval. That's assuming it doesn't want to revisit the clinical data, and that it has already reviewed the data that ARLZ's PR this week said showed bioequivalence to the original supplier's aspirin. So obviously no guarantees but I think there's a decent shot at early approval.
Bruno, Tuesday's PR included the following: "In addition, Aralez worked directly with the new primary aspirin supplier to help prepare it for a previously planned inspection by the FDA. The FDA inspection has recently concluded and did not result in any reported compliance findings."
Compare that to the PR that ARLZ's predecessor POZN issued on Dec. 28 regarding the previous supplier: "POZEN also announced that the FDA has completed re-inspection of the manufacturing facility of its previously designated primary aspirin API supplier and issued an additional 483 notice, citing numerous observations." So while there hasn't been a formal announcement that the new supplier has been approved, it has been inspected and apparently passed inspection.
Well the FDA accepted the revised NDA in under 2 weeks instead of the statutory 30 days and it inspected the new facility pretty promptly so I'm optimistic. And in the last quarterly CC an analyst asked Adams whether if the FDA approved early ARLZ would be prepared to launch and he said yes.
If as appears to be the case the FDA's Compliance Division has now signed off on the manufacturing facility and there are no remaining manufacturing issues the NDA now goes back to the Reviewing Division which two years ago found no other issues. So unless the Reviewing Division decides to revisit parts of the NDA that it previously found acceptable -- which it always has the right to do but usually doesn't -- it could theoretically announce approval at any time. Of course it could wait until the September PDUFA date but it doesn't have to.
The FDA also responded early. It had 30 days from March 14 when ARLZ filed and it apparently responded by last Friday, March 25. Don't want to read too much into that but it suggests that the FDA may also announce approval before the September 14 PDUFA date. That's only an outside date -- the FDA always has discretion to decide earlier and it frequently does.