Kyelion, I am unaware of any legitimate poster here celebrating the stock decline. It sounds a lot like a straw man argument that you are making.
Some of the "others" you mention are spammers. They never contribute anything, unless you count making the same gripe on a daily basis. Some of them are very nasty. I put them on ignore.
I get tired of the Raj bashing, especially when the same poster keeps repeating it. Mostly, this is done to ruin any positive experience from coming to this mb (sharing information, discussing genuine opinions, etc).
Spammers are here and they are on both sides. No reason to give any legitimacy to posters who clutter the board with drivel.
Unfortunately there is not much going on with this board, and spammers like to crowd out what little is here right now. We have a good group that comes out of the woodwork at times, I am guessing they are busy people and only check in when there is something they need to discuss.
On a lighter note, you are a critic of Raj, but you make regular contributions here, which I appreciate.
Search "LUN240 protocol update." You will see some links from VA cancer around 2nd or 3rd one down. You can follow the sequence of monthly updates through the summer where this trial goes from "on hold" to not appearing on the list.
I also found a similar list from one of the other sites, I believe in OH. This trial was also listed as "on hold" during that same period.
There was a thread started by csat a couple months ago where we went back and forth about it. I believe it is on pg 1 of his post history, as he hasn't posted much lately.
Search "IRL-1620" for more information on SPI-1620 and Alzheimer's disease.
Still concerning that the P2 NSCLC trial seems to be on some kind of hold. Hoping csat jumps in, he was the one who first mentioned it in a thread.
Tartia, not sure if you were involved in the last debate on the status of 1620, and I don't mean to rain on your post. I have found 2 sites that listed the NSCLC trial as "on hold." After this, one site even removed it from their list of trials in a later update.
Now, I don't want to speculate too much, but I would doubt that this would be for a positive event. The randomized part of the trial was only supposed to commence if there were 6 CR/PR out of 27 patients in the control arm.
Things got a little quiet on SPI-1620 for a while now, and the NSCLC trial has not been updated in a while. The Biliary cancer trial is still listed as recruiting but was also updated around the same time.
Perhaps this program is on hold like some of the Zevalin trials? Opinions welcome
Anti, just to add to your post, Lee Allen on the Q2 call stated "We've already seen, our own case as an example, where sometimes decisions are made earlier than that. So we're very optimistic about the timeline for review."
Speaking of the timeframe for FDA decision on CE melphalan, and the early approval of Beleodaq.
Anti, certainly with belinostat they took the extra time with the FDA and it paid off with approval in 5 months. This makes it less concerning to me that they are giving a longer timeline.
As far as Apaziquone, I am thinking that ship has sailed. Another P3 trial is probably dependent on how much the FDA really likes the pooled data. They can't like it too much or there would be movement on the program already.
Try calling IR and asking about the status of current Apaziquone trials. I could not get an answer on whether they were active, finally gave up and left a message, never got a response. It's probably the same reason why they stopped talking about SPI-1620.
Yes, they would be prohibited from the marketing in the other indication. However, a doctor can prescribe the generic off-label, and nobody can stop such a practice. I am going to try to find other similar recent examples to get a better idea.
Joe's point on the doses is intriguing. If an ANDA can only be for osteosarcoma, obviously it will be for a particular dosage. I suppose this would block a generic from the mCRC market, which is probably around 90% of Fusilev sales.
Either way, melphalan approval and some positive SPI-2012 data and SPPI will be owned by big pharma.
Joe, my understanding is that the orphan drug status for osteosarcoma runs out in 2015. According to FDA website, a competitor could seek approval only in that indication. Then, in theory, the generic could be used off-label for mCRC.
It is important to be clear that Fusilev received orphan drug status twice. The newer one does not extend the live of the older one.
IMO the patent case is highly important and is a gateway for a generic to enter the market. Of course, generics would have to win this time and again on appeal.
Then the question becomes how much of the mCRC could a generic take? There must be a similar case out there. I'm guessing it would be significant over time.
I would bet against the generic manufacturers in this case, but this is still a debate worth having.
Suppose it is neutral, but you can tell it's a struggle for him. He avoids any mention of SPI-2012.
Melphalan is really what is going to move the shorts out of this stock, and he knows that.
cigan, you are deliberately deceiving people- SPPI did not buy CASI or their stock. You and your buddy invisiblehand seem to think you are smarter than the rest of us. Try explaining it for us in detail, then, instead of using one-liners and general terms (such as how Chinese "DO" accounting). Help us understand, oh wise one.
Agreed, but we can't be surprised anymore. They have been kicking the can for a long time on Apaziquone. They have not treated it as a priority. I am curious as well, but my expectations for Apaziquone are zero. It would be better to come clean, but they like being secretive about these things.
I recently came across the Tenncare website which has both drugs listed as covered injectable drugs, however only Otrexup requires prior authorization. Rasuvo does not. I have been unable to find similar examples from other providers, though it would be logical to assume there are more. Any theories? Otrexup seems to always require prior authorization, why not Rasuvo.
From the few I could find:
University of Minnesota- addition to tier 2 (effective 10/1)
Blue Alert TN- added to specialty/pre-authorization (effective 10/1)
Blue Care MI- not covered
Curious to see how the see how the launch trajectory is going in Q3 call.
Joe, strangely not much talk on here of Apaziquone change on product page. Do you remember it recently stating 2015 and then a change to 2014?