Bull the FDelay is a government bureocracy and s such early completion of their work is not in their wheelhouse. If they were to complete work early then they'd get less time to waste on the next job. My expectation is that PDUFA date is 8/18 and that is when they'll render the decision. I'd be worried if the PDUFA gets dayed.
Agree and do feel better? Also went over last Dec press release. 43 month pfs vs 24 placebo. Can't see how not approved. In addition I thought drs already using for this indication off label from last call. Thanks- think we have a Baker winner here yet get concerned at times due to magnitude of holdings. Need to get back to long term perspective and keep eye on prize.
I hear ya. If it helps you sleep well this weekend, I just went back over the transcript of the last conference call. Here's Siegall on the matter: "Looking ahead, in the near term, we anticipate an approval decision from the FDA on our AETHERA Supplemental BLA by the PDUFA date of August 18. A positive outcome would result in a third indication for ADCETRIS and represent a key step in our goal of expanding ADCETRIS beyond relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma."
Keep in mind, this was just 19 days before the PDUFA date. One has to believe that if the company sensed any problem, he would not have chosen those words.
Thanks. Need SGEN to hold up. It's my biggest holding and I am getting pummeled on my second biggest CHK and other energy. Should SGEN gt hit hard-I'm in trouble. No college for kids and need to work unil 90 to retire. Lol.
Sentiment: Strong Buy
Though I always harbor some concern, I can't say that I'm overly concerned about this. I can't speak to the science, although approval certainly seemed like a lock, but here's my theory about what might be happening behind the scenes:
If I recall correctly, these kinds of approvals are not publicized by the FDA; rather, they are communicated directly from the FDA to the company. If, as I suspect, that approval is communicated to the company after the market closes on any given day, a PR-savvy company (which, admittedly SGEN not always has been) would announce the news until just before the market opens on the next market day. This gives the announcement more affirmative market power than letting it lose steam over night - and certainly more market power than letting it lose steam over a weekend.
Bottom line: Though my speculation about today was not correct, I'm still guessing that we hear positive news early Monday, early Tuesday or, worst case, early Wednesday. (FWIW, Leerink Swann raised its SGEN target from $53 to $56 today.)
Based on the calendar and trading patterns, I'm guessing that we get the news after the end of trading today or, at the very latest, Monday.
Yep. Bad day yesterday for CLDX, but I don't have all that much, so I can ride it out and see what happens. You?
Conclusion: Brentuximab vedotin is both active and well tolerated in cutaneous T-cell lymphoma and lymphomatoid papulosis, with an overall response rate of 73% and complete response rate of 35%.
True to my statement I added 3 times today, at high 44. Considering we are a week away from FDA ruling and (I assume) label expansion, today was a bargain IMHO.
$45-48 looks to be a decent place/price to add....but, in truth, only the BB (and the overall market) will determine the best place/price.
I'm not concerned in any way about the increased losses reported as the company is adding personnel, new technology through its partnership and continues to speak out more favorably about its pipeline and ADCETRIS potential.
I would outright say that they overenphasis on CD33a conveyed overconfidence in that the FDA will be again compelled to approve afr PII.
As a shareholder it is comforting to know that this crew is overseing m investment.
They are sharp as a wip and on the ball and focused on the prizes rather than patting themselves on the back.
Highly unusual to start talks with the FDA on a drug at completion of only phase 1. I thought the data looked good from the last two abstracts on 33a bearing in mind that a MTD still had not yet been reached in the phase 1 dose escalation study.
In yesterdays CC they must have said " encouraging " and " strong" at least a dozen times when referring to 33a. If the ADC holds true to pre-clinical form I can envision PFS being vastly better with 33a than current treatment regimens, especially in the unfit AML population. Actually the words strong and encouraging sounded more like understatements as mgmt. here has always tried to play it cool. Regardless, AML is a huge unmet need with a good chance of greatly accelerated approval on strong data.
I think the Adcetris program is moving ahead nicely, and the DLBCL data looks very strong, but it is sure nice to see the dialogue moving beyond just Adcetris and getting some focus on the pipeline.
From Conference Call: "we believe ADCETRIS will become a blockbuster product. And so that's one thing that we're doing."
Not seen that level of confidence that it will be a product before in previous CC. In addition CD30+ new indications are moving smoothly. In spite of the run this year, it is still a bargain. Although I have a huge position I decided I will add on dips.