TELESTA THERAPEUTICS INC T.TST

The Impact of Advisory Committee Votes

[givmeabrake]

Looks like a slam dunk to me

Study between 2008 - 2012

NOTE: MCNA was granted a priority status and is meeting with Oncology Adcom

169 Total Meetings

22 Oncology Drug review

77 assigned standard designation

77 granted priority review status

15 orphan designation

Yes vote

Standard = 45

Priority = 59

Orphan = 9

Approved by FDA

Standard = 37

Priority = 53

Orphan = 9

Specific to ODAC (Oncology Drugs Adcom)

Yes vote

Standard = 5

Priority = 15

Orphan = 2

Approved by FDA

Standard = 4

Priority = 15

Orphan = 2

https://lsconnect.thomsonreuters.com/fda-advisory-committee-votes/

[HighteawithIntrepid]

GMAB as I said a thumbs up from AdCom is pretty much a 100% yes from the FDA so we're closing in on 35 days from being able to order that expensive sports car. Anyone out there interested in a bulk Boxster purchase on November 19th? HT

[IWillRetireSoon]

Sorry I already bought my car in the spring.... NowRetired

[givmeabrake]

Guess you should change your handle. 

[1wascallywabbit]

Counting chickens??? Don't spend the paper money yet. There is still risk. Derisk capital on the way up - the prudent thing to do.

[DamnYankees]

GMB, if I read your stats correctly 15 of 15 oncology "priority review" submissions in this period received both a Yes from their Adcomm meeting and final approval from the FDA. 15 of 15? Huh.

[givmeabrake]

That's what I'm reading. With the Oncology Drug Adcom that is. I could be wrong but it appears to be a priveledge to be reviewed by peers. The report stated an average of only 33 Adcom meetings per year between 2008-2012. Wonder what % that is of all FDA applications? https://lsconnect.thomsonreuters.com/fda-advisory-committee-votes/https://www.ca-biomed.org/pdf/media-kit/fact-sheets

[DamnYankees]

Must be that only you and I are reading it that way. Sure there isn't another interpretation? That batting average seems too good to be true.

[RetailRube]

Gimme, I vote your post about AdCom results as the best I have ever seen on Stockhouse.  Thanks for digging.  What surprises me was how soon AdCom was scheduled.  A week before US Thanksgiving.  When I worked in New York, we tried to clean up all the year's business prior to Thanksgiving so in December we could work on bonus calculations, to have everything buttoned down by

[Frogger2]

Once ADCOM has completed their due diligence would the outcome be public or would this be kept private and passed to FDA? 

[HighteawithIntrepid]

Frogger If you look at the minutes of the last bio meeting of AdCom the voting was done by 5:00 ish that day. Since executives of TST will be there, I expect a press release at 5:30 pm more or less from TST on the 18th  announcing the vote count. One way or the other this will be the biggest news since we sold the Animal Health business. HT

[txbioinv]

You can follow the Adcom live via webcast and actually listen to the final vote recommendation live. I have considered attending this event, anyone else thinking of going? I have listened to several Adcoms live; sometimes even professional bashers as Fraudstain are there doing a blow by blow detail live blog. ADD NOW while you can, sooner that later good news but more importantly the float will be