ANX submitted a NDA (new drug application) to the FDA during the last week of December 2009, and the FDA has sixty days to give the company it's decision if it will accept the application or issue a RTF Letter (refusal to file letter). That means that the company most likely has already received the FDA's decision, and they have 72 hours after receiving the decision to issue a Press Release about the decision. There should be a PR about this released during the week of March 1st to March 5th 2010.
There has been a lot of talk this weekend if the FDA accepts the NDA for ANX-530 will it be eligible for either Fast Track or Priority Status, which would reduce the number of months until it's PDUFA date. A normal time frame for a PDUFD date to be set is ten months from the date the NDA was submitted. Since the NDA was submitted during the last week of December 2009, the Normal Review PDUFA date would be set for the last week of October 2010. Receiving an accelerated review with either a Fast Track or Priority Review Status would reduce the PDUFA date by a number of months depending on which accelerated status it receives.
In order for a NDA to be classified with an accelerated status the company must request it when they submit the NDA. We have no idea if ANX requested a Fast Track or a Priority Review when they submitted the NDA application.
There are a lot of traders on the many message boards I am a member of, and blogs that I read that think the share price of ANX will skyrocket up once we get the PR that the FDA has accepted the NDA for ANX-530. In all of the years I've been following FDA plays, I've rarely seen a huge move up on just the news that a NDA was accepted.
There may be a nice move up on the day the FDA news is PR'd due to retail buying and maybe a little bit of Short Covering. But as soon as buying volume drys up I have a feeling the Shorts will be adding to their positions again in an attempt to hold this stock down like they've been able to do most of this year.
The only times I've seen a large and sustainable increase in the share price is if the FDA assigns either Fast Track or Priority Status. When that happens, the market really takes notice and the share price soon reflects it.
If the FDA accepts the application that would be very good news for this company because the FDA is not only ruling if the drug ANX-530 is worthy of further review, but more importantly that their proprietary emulsion process also has merit. Every new drug this company has in it's pipeline and plans to submit to the FDA for approval is based on this unique and patentable emulsion technology.
During the past two months, there has been a lot of talk about a buyout, takeover, or partnership of ANX by either GlaxoSmithKline (NYSE-GSK) or Sanofi-Aventis (NYSE-SNY). The reason one or both of these huge drug manufacturing companies would be interested in in taking ANX over is because they both stand to lose a lot of potential market share if ANX's drugs go to market in competition with their existing drugs.
ANX-530 would be in direct competition with GSK's drug Vinorelbine, which has a worldwide annual market estimated at around $200 million. ANX-514 would be in direct competition with SNY's drug Taxotere, which has a worldwide annual market share estimated at around $3 BILLION! Not only would they be removing competition from their existing drugs, but they would also become owners of the proprietary emulsion technology that could be applied to many other existing drugs to make them safer and more effective.
Usually, when a buyout offer is tendered, the offer price is between 300-500% above the current share price. ANX is currently trading at around $0.30 per share so a 300% increase would put the buyout offer at $0.90 and a 500% increase would put the buyout offer at $1.50 The traders that are calling for a buyout offer between $3.00 to $4.00 are dreaming in my opinion.
There are many traders that entered Long positions hoping for buyout to happen, because they have done their research on this company and know it is a definite possibility. If they hold a sizeable position between $0.15 to $0.50 they stand to make a nice profit if a buyout offer is tendered.
I am one of those traders, but I didn't enter my position just because of the possibility of a buyout. I have looked into this company's history, and there has been a lot of good changes made since the previous CEO ran the company. But the bottom line is I think that their technology is fantastic, and it will be able to make many existing drugs much more effective and safer.
Here is a three month/daily chart of ANX. It ran from below $0.10 to $0.52 in the past few months, and it has held half of it's gains which shows a lot of strength and is considered Bullish. Keep this stock on your radar next week, because if the PR comes out saying that the NDA for ANX-530 has been accepted there should be a nice move to the upside. If the FDA assigns an accelerated review process designation, there may be a very large and sustainable move of the share price to the upside. In My Honest Opinion.
Happy Trading,
zigzagman
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