At first I was skeptical of SGENs first drug approval (single arm study) but longs convinced me otherwise. Now I have to ask, does anyone have specific dates on when we should hear from FDA? I read Q3 2011...does that mean July is the earliest it could get approved?
Also, as always, keep an eye on Celldex. If SGEN drug gets approved, CDX 011 should get the spotlight after. Obviously, SGEN is a much different and mature company with multiple big pharma partnerships and near term revenue possibilities, but CLDX at a 140 Million Market cap is basically a call option with LOTS of upside.
i possibly gave someone inspiration.
that someone bought 2500 contracts of May 12.50 puts today,
to hedge 250k shares probably.
about $90k spent
wow, 250k shares!!!
i want some $ come my way for the idea.
we are all getting paranoid here
everything else is flying
INCY hit $18
it is sad to see SGEN still at $15s
i wrote an email to SGEN today protesting the insider selling
sooo f*ing irresponsible they have been
My son took his first dose of SGN35 on March 23rd. He was literally on his death bed after failing ABVD, transplant, HDT and another clinical trial drug. He is on 24X7 oxygen, catheter for draining lung fluid (a previous clinical trial drug gave him drug toxicity in the lungs)
He is doing much better after one dose and NO side effects. He is hungry as a horse, heart rate is down from 114 to 88, saturation levels were 90 when he was using 8 liters of oxygen. Now they are 96 on 2 liters. Just frickin amazing. Anyway, his oncologist said that submission will come this summer and approval by Sept. I just bought in today. Good luck everyone
My son received his 3rd dose on Tuesday of SGN-35. He also had a complete set of scans done. Compared to the scans taken before he started SGN35, there is a 'significant improvement' between the two. Cancer is gone from all his organs and has decreased between 50-100% in size everywhere else. Just unbelievable!! He did not have to use a bit of oxygen this past drive from central florida to Houston so we can now start flying. Even if I ended up losing money on this company (won't happen though), I owe them a great deal. I would love to meet the scientific team that was involved with creating this awesome drug. And he continues having NO side effects. Sorry for getting off topic here. Obviously a single patients results does not tell much.
Thank you for sharing your story. It is heartwarming to know that you have been given a ray of hope. The strides being made by companies like Seattle Genetics and other biotechs have given those suffering faith and hope, which may never have been available previously. Best wishes to your son and the rest of the family. It must be a terribly difficult time for all of you. God bless.
Jandk: Ever since SGN-35 went into field trials, I've been tracking comments in disease support forums and have seen many similar reports.
All are heartwarming, but your post was particularly so. Thanks for sharing your son's experience. (BTW, SGN-35 already has been submitted to the FDA and a final response, presumably and hopefully approval, is expected during the second half of the year.)
Yes, we all hope for good luck with our SGEN investment, but you have very much more riding on Seattle Genetics and SGN-35 than do we. I hope -- and expect -- that your son will enjoy a substantial, even full, recovery. I'll be thinking of you.
just as in "just in case".
i bought them a short while back.
see my post on april 4th.
i was worried to buy more shares
but was able to do so with the option hedge .
so all in all it wasn't a waste perhaps.
If accelerated process is announced next week, approval should be announced as early as last week of July.
Now, you probably should quit pimping CLDX here since many SGEN longs are either CLDX holders or have been studying CLDX for awhile. I am a holder and have also been pumping CLDX here. Go pump in the MITI or VRTX board instead.
To be technically correct, it is a Priority Review (not Accelerated Approval) that sets the PDUFA date at 6 months, and it will certainly be granted.
The acceptance of the BLA and granting of Priority Review will be announced in the next couple weeks.
[Accelerated Approval is about getting approved when the endpoint has not yet be PROVEN to be clinically significant. It came up with AIDS, where final proof would take 10 years or so.]