There are some indications that there is a substantial increase in incidence of Guillain Barre and SGN 35. Is this already reflected in the stock price? Are we fully expecting front line approval for this medication and is this factored into the stock price?
As I recall reading months ago after the bankers' analyst tried to scare off sgen investors by emphasizing the peripheral neuropathy side effect, when tumors shrink, even naturally, they give off substances that can cause periperal neuropathy. So what can you do when a side effect could be a sign of success?
Patients in the trials have been under other cancer treatments that can cause the same side effects as sgen and which can show up after those treatments ended.
On SGN-35 orphan, I believe the patent estate outlasts the 10 year orphan designation, so that is not an issue.
I do agree that SGN-35 will easily end up being used early in all CD-30+ cancers. They need a little more trial data, but once that is published it will be like Ritux in CD-20+ lymphomas. [I am not claiming SGN-35 is a Ritux type blockbuster, obviously CD-30 is over-expressed for less often than CD-20].
Semi OT: It is unfair to compare the nature of the T-DM1 results with the SGN-35 data. T-DM1 was trialed in patients that already had become refractory to Herceptin. I think there is near universal agreement that the data on both drugs looks good.
With respect to the safety data, there was a 4% rate of grade-4 peripheral neuropathy, no separately reported GB numbers I have seen. So either the 4% includes GB, or there were no GB AEs reported.
GB is treatable if caught early. I would expect that this would either be a non-issue, or else be included in a black-box.
I would think the biggest real concerns would be those coming out of the blue. We should know all when we se the briefs.
P.S., A nitpick, your use of the term "Fast Track" is wrong here. It is "Accelerated Approval" that always involves the use of a surrogate endpoint that the FDA is getting nervous about. "Fast Track" is a broader designation that includes verious speed-ups (usually a Priority Review) along with the possibility of Accelerated Approval if the trial endpoint so indicates.
I think the biggest risk along these lines would be that the FDA would consider the P2 trials sufficient for an AA only, and require that the P4 confirmatory trial already be underway before issuing the approval.
I think your mixing up SPA/Fast track as if it goes hand in hand with a pivotal phase 2. Fast track and SPAs also, and generally, apply to double arm phase 3 as well so the connection your making is incorrect.
If one member on the panel doesn't like a specific policy, he is only one member. Pazdur may be in a leadership position but he is not supposed to be involved in Biologics which is where we stand.
Also the previous questionable thumbs down decisions he made involve minimal benefit to patients, for example; DNDN trial results only extend life 2 1/2 months.
Point is SGN-35 is in a whole different ball game. There is no question in the benefit to patients.
I recall an article referring to the policy changes by the FDA about ME TOO drugs and minimally beneficial drugs. They were looked on unfavorable by the FDA and for some reason Pandurs name rang a bell.
Again our company is a whole different story. the debate doesn't fit SGEN results or end points.
Sorry beg, the FDA (Pazdur) does not like the fast track for approvals since they often include a surrogate measurement like extension of life or tumor shrinkage, etc... The FDA would of course like to see big phase III trials with nice and tidy data so they don't have to any interpretation of the data. Go to Gekkowire.com and search for Pazdur. You will find a July 2010 article where he is interviewed and speaks out against accelerated approvals.
I'm not short, in fact I do not have any SGEN at this time. I'm very interested in the FDAs perception of this ADC as I am very very long IMGN and this is about as good a predictor as you could get for how the FDA might look at their ADC.
Dbeg I have to agree with you on this one. There was a SPA, and the results greatly exceeded the SPA hurdles as it relates to HL. As it relates to ALCL, there wasn't a SPA, so that to me is the greater risk, if there is going to be an "approvable' letter. However, as the company has said, even if they had more patients and they were all no response patients, the data would be better than the bar would be for approvable.
Understandable but I had IMGN when they were turned down. This isn't the same thing. Imgn didn't have a SPA, or the stellar results to back it up. Finally the FDA looks very favorably on these orphan drugs. The government backs it up with a longer marketing protection than standard approved drug so they can recoup more investment dollars. It the case of SGN-35, this gives SGEN more time to explore other indications for CD30.
This drug has tremendous potential in the near future.
Beg, CH is an IMGN long and got burned with the rest of us with the refuse to file decision of the FDA on T-DM1. Thus, his concern with how the FDA might mess up SGEN's accelerated approval decision.
most of your post is B.S.
I like the one new point you try to make about the FDA not being a fan of fast track. That's a new one and complete garbage. There is nothing anywhere to support that. In the case of SGN-35, the FDA has been lock step with the whole process which is evident in the SPA.
I've seen you around in the past on other boards as well as here. Almost always on the short size. You can take your vertically challenged strategy elsewhere. The members on the board have heard it all and are very savvy to the short deception strategy.