is amazing, selling on news couldn't hold it down today. they're on to something good here. maybe the answer to our energy problems. wish i'd bought at 25 and change today
Analysis of PFS
Missing data can complicate analysis of PFS.
The protocol should define an adequate
assessment visit for each patient (i.e., a visit wh
en all scheduled tumor assessments have been
done). The analysis plan should outline a comp
arison of the adequacy of follow-up in each
treatment arm. Methodology for analyzing inco
mplete and/or missing follow-up visits and
censoring methods should be specified in the prot
ocol. The analysis plan should specify the
primary analysis and one or more sensitivity analyses to evaluate the robustness of the results.
Although any analyses with missing data can be
problematic, the results can be strengthened by
similar results in both the primar
y and the sensitivity analyses. The evaluation should include
the number of deaths in patients who have been
lost to follow-up for a prolonged time period.
An imbalance in such deaths could bias
the PFS measurement by overestimating PFS in the
treatment arm with less follow-up.
Because progression data can be collected from
multiple sources (including physical exams at
unscheduled visits and radiological
scans of various types) and at
different times, data collection
for each assessment visit should be limited to
a specified short time interval around the
scheduled visit. Difficulties can arise in determining the event date and censoring date when
data are collected over a prolonged time period.
We recommend assigning the progression date
to the earliest time when any progression is
observed without prior missing assessments and
censoring at the date when the
last radiological assessment dete
rmined a lack of progression.
Appendix 3 provides a set of tables
for potential analyses of PFS that
can be used for primary or
sensitivity analyses. Plans for PFS data collec
tion and analysis should be discussed with the
FDA at end-of-phase 2 meetings and verifi
ed in special protocol assessments.
today is the fulcrum, there's been 2 months which they claimed to need throughout phase 2 for data interpretation. We are gonna ride one way or the other today. Gentleman and ladies, place your bets!!!
CEO slated for presentation at BIO CEO conference in NYC on 2/10 or 2/11. that's when any flup news about phase 2 should be released
this is significant to say least, we'll know who has been buying up all these shares by next Tues or Weds. From SEC Website: Schedule 13D is commonly referred to as a “beneficial ownership report.” The term "beneficial owner" is defined under SEC rules. It includes any person who directly or indirectly shares voting power or investment power (the power to sell the security).
When a person or group of persons acquires beneficial ownership of more than 5% of a voting class of a company’s equity securities registered under Section 12 of the Securities Exchange Act of 1934, they are required to file a Schedule 13D with the SEC. (Depending upon the facts and circumstances, the person or group of persons may be eligible to file the more abbreviated Schedule 13G in lieu of Schedule 13D.)
some body/company/thing definitely got 5% between today and 17 Jan, u saying we'll know by 28th? that's great if true, shed some light on this volumness mystery
how do half outstanding shares change hands in 2 days of trading with 400% volume with no news? don't get it
9 million shares outstanding, maybe make money next quarter maybe not, 100% run up in last 4 months, perfect target for shorts, meets exactly profile they look for, earning not out for at least another 3 weeks, so now would be time to short, and watch, when earnings come out, the short will happen again. volatile stock where shorts prey on those that invest EMOTIONALLY!!!