And still no movement in the pps. Waiting for more details when they report the initial dosing for PLX-106. Will probably stay invested at least until the P2 results expected by the end of the year.
When I enter Yahoo Conversations ATRS, it takes me to this board, not the Summary page. And when I go to the Summary page, I don't see anything labeled Conversations. I am a bit puzzled.
Two sites, 24 patients, starts Q4. Results and resubmission H2, 2017. Talking with potential partners to license 115.
With all preliminary studies completed, AMAG will soon begin enrolling patients for this trial, 120 in all, which they estimate will take 3-4 months. A pain study, with 60 enrolled patients, will take place concurrently. In both AI is being compared with IM delivery. In the first one they are looking for equivalent bioavailability, in the second a statistically significant lesser amount of pain with AI. It appears the results will be available in Q4. The pain study is required to support AMAG's request for an additional seven years of orphan exclusivity.
I guess it's a mild negative that we go back to a ten months review, but the potential seven years of orphan drug exclusivity for Makena will greatly benefit both companies.
I should add that they COULD monetize future Remoxy royalties in exchange for a lump sum, and in fact did mention this as a possibility in one of their conference calls. This would of course provide them with some more immediate financial relief.
OK article, but I think he is too cautious on the approval chances. Safety and efficacy were never an issue. The availability of the very low dose is a strong plus. Canceling the AdComm was also a very positive signal which he did not mention. I think the odds are very good this time. Where I really disagree with him is his view that Remoxy can somehow save DRRX from dilution. It will be quite a while before there is any meaningful income from Remoxy, assuming approval. Much more important is cash they may receive if deals are done involving Posimir and DUR 928. If DUR 928 achieves its apparent potential, a little dilution will be inconsequential. But we have to have some persuasive trial results. As of now, Durect isn't even being included in Seeking Alpha articles on companies developing NASH drugs. I hope they can present at the Morgan Biotech Conference this January--that's the biggie.
Remoxy is likely to be approved, and it could be approved before September 25. And the end of September will also possibly bring 928 P1b results, as well as the first 928 pre-IND meeting with the FDA. Fortunately, Durect is still ahead of Heron with POSIMIR, as that company has just completed P2, but has yet to initiate a P3. For those who are into gaps, we have a 1.85-1.90 gap to fill.
About 70% of my position was bought in the 2s and 3s. The rest, bought in the low 5s, I have been gradually selling and replacing with shares at the current price.
But if there were an AMAG-like deal, it's highly unlikely that any details would be revealed any time soon. I may be wildly overoptimistic, but with QST, Makena 3.0, and (perhaps) Epi in the offing, I think a share price collapse is unlikely.
If what you say is true, shouldn't the participants in the ARX-04 trials be complaining loudly about the slow onset of pain relief? And yet for some reason they don't seem to be confirming your thesis. When will you at long last throw in the towel? You remind me of Ackman--more interested in being right than in making money.
And in a very short amount of time. It closed today just above the 200 Day MA (3.62). Coming up there are multiple data presentations, the first one in two weeks, an Analyst's Day, the start of the Zalviso trial, and the NDA submission for ARX-04. And that's all in the next five months!
With positive cash flow, they can accelerate the development of their own products, and they can make some acquisitions. ANIP has done several relatively low cost deals with Teva.
I agree that $2 is a pretty obvious near term price target, with analysts turning bullish on Remoxy. Above $1.50 there is no technical resistance before $2.