I though Human Genom (HSGI) already had the drug approved. You are saying it is still in trial ? I will surely be interested if it is still in trial.
The cleansing of DNDN shares is closer to the end. I know the volume not necessarily indicates ownership but there should be a co-relation. Close to 110 M shares have changed hands over $50 and it will be interesting to see how it goes near-term....
1) HGSI and its partner GSK will submit Benlysta BLA and EMAA within the next two months. The two independent trials results were announced last July and September, the primary endpoint (efficacy at the 52nd week) was met and exceeded in both and that is what the BLA and EMAA regulatory decision is based on. The recently announced non-significant results of the secondary endpoint (efficacy at the 76th week) should bear no material impact on the regulatory ruling. From where I see things, trial risks are completely removed and approval risks are minimal.
I have talked to a few people who know a thing or two about Lupus. Simply put, it is a very terrible disease (of course, all diseases are terrible). Peak market potentials (2015-2016) estimates are anywhere from 4B-6B. As such, I view HGSI grossly undervalued and will have a small stake for the long holding. My first small entry caught the downdraft along with the market but I am not done with it yet. With my current highly limited knowledge about it, I will forgo options.
2) DNDN will be my biggest holding for the long haul (I have yet to build my line of position). The post-FDA momentum was killed altogether by MG's monumental sale and I don't expect big movements around here until the next catalyst hits. The long expected ROW partnership is dead at the moment but life with DNDN never gets boring. I expect buyout rumours to be flooding in the not so distant future again but I don't work with all of that. I work with facts as I know them. The reason I closed my entire line of position was very simple, I held May calls. If I had shares/LEAPs, I would not have done a thing. In my mind, the next catalyst will be Provenge sale numbers, a good-sized secondary (1-2B, my own speculation, going ROW solo will need to burn a lot of cash), and the announcement of Nuevenge Phase II/III trial initiation (there were unconfirmed earlier talks about the FDA letting jump with Phase II since there was no safety concerns arising from Phase I). EMAA filing will take a back seat in the short term. Off label use of Provenge will be a big plus on the sale side but that is years out since DNDN is facing a capacity bottleneck rather than insufficient demand. The top-dog management is a dream team except MG's extreme financial selfishness (he clearly shows some character flaws too but as a small shareholder, I don't have to deal with that. Love him or hate him, the guy took Provenge to the FDA approval at the helm).
3) ITMN is in the dog house now. I will simply collect the difference in my spread by OE and let good traders squeeze the last few points that there are to be squeezed possibly. Should a powerful deat cat bounce occur, I will open a new line of puts position.
4) APPY is approaching the red zone and things will surely get volatile/violent with such a small float. I need to get over with the trial risks before thinking of a longer-term strategy. Should the pivotal fail, nothing there to think about. I am one-directionally fully loaded now (added a little May 5c yesterday in the small-scaled shakeout). This is a day-to-day thing. I have a GTC order in in case of violent shakeouts for a little more shares. I have seen enough of that kind of shits going on in bioland that having a GTC order feels prudent. No assurance of its happening. I did that with DNDN and it never materialized. I ended up with sitting on a pile of cash that I fully intended to put to work.
5) LVS and MGM ER's are out today. Oh boy, both took heavy hits over the last few days. This is nothing untypical in the high-beta space, pre-earnings jetteries in the hugely down market only.
I need APPY to come through for a biotech trifecta. If Lady Luck hits, my working capital base will materially improve. I will take a breather to establish a holding strategy going forward, likely tuning down options plays. Living on the edge is very consuming. It is ok for a short period of time but can't go on forever. I am only a moonlighter, after all.
