May 16th it is - Yet Another Day of Anticipation

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Ryan
Posts: 38
Joined: Sat Jul 08, 2017 1:41 pm

May 16th it is - Yet Another Day of Anticipation

Post by Ryan » Fri May 03, 2019 2:21 am

OK, let's have some conjecture from some, inquiring minds want to know.

I think we can rule out any sort of FDA provisional approval, that would be the pie in the sky, and would be an immediate release.

Most likely, in my opinion, the transfer of IND from Janssen is complete. I am presuming here it is pretty much complete at this point ~ just some i's to dot and t's to cross, and they are giving a 2-week cushion to ensure everything is finalized and ready for public release of this news.

Maybe just maybe, we have initiation of Phase III - doubtful, but maybe (just maybe) they have patients scheduled for dosing.

I'm sticking with transfer from Janssen. What do some of the highly-educated-in-all-things-Imet here surmise??

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: May 16th it is - Yet Another Day of Anticipation

Post by biopearl123 » Fri May 03, 2019 4:15 am

Ryan, yes maybe transfer will be complete but May 16th is the day the EHA abstracts are released. MDS durability may be confirmed and maybe a few more 8 week converters,that ought to do it. Non US partner may be too much to hope for yet. bp

Secret Third Arm
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Joined: Tue Aug 28, 2018 3:26 pm

Re: May 16th it is - Yet Another Day of Anticipation

Post by Secret Third Arm » Fri May 03, 2019 2:48 pm

Ryan, if there are several more durable TIs then the numbers become significantly better than Luspatercept and perhaps the market will finally realize that Imetelstat is not just 'as good as' Luspatercept, but is actually a better drug. Certainly the sicker population with higher transfusion burden should have demonstrated that, but perhaps it was too much to expect retail investors to understand the nuance of those numbers.

Assuming Imetelstat has a few more TIs in the expansion cohort we would have much better than 37% transfusion independence. Then it becomes really difficult to NOT see the advantages of Imetelstat over Luspatercept. These are the follow up numbers that Dr. Steensma said would be presented by his colleague at this year's EHA.

Coincidentally, the abstracts for EHA will be released in Europe on May 16th, which means they will be available before Scarlett's conference call and before the market opens. My guess is that the abstracts are online at 4am EST (9am GMT) then we get a Press Release from Geron at 7:30am EST and then the call at 9am EST followed by the market open at 9:30am. Perhaps Dr. Riza will host the conference to discuss the abstract and finally share her thoughts on Imetelstat. God willing, she's much more enthusiastic than Scarlett.

-Bridge to Sell

Gwikley
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Re: May 16th it is - Yet Another Day of Anticipation

Post by Gwikley » Fri May 03, 2019 11:50 pm

And this CT filing adds to the mystery.

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: May 16th it is - Yet Another Day of Anticipation

Post by huntingonthebluffs » Sat May 04, 2019 12:44 am

The confidential treatment (CT) order covers areas in regards to the contract with Parexcel , the CRO. I scanned the two exhibits 10-42 and 10-43 and looks like it covers names, phone numbers, emails, schedules, treatment of patient info, supplies, etc. I don’t think there is a lot of mystery in what they wanted with the CT but I could be missing it.

http://ir.geron.com/static-files/a786cd ... bfbf5a5d6a

http://ir.geron.com/node/15921/html#ITE ... TEMENT_SCH

Ryan
Posts: 38
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Re: May 16th it is - Yet Another Day of Anticipation

Post by Ryan » Sat May 11, 2019 7:02 pm

Well, we have no new hints at all about what is to come on Thursday.

BioPearl, I've certainly come around to your inclination, which is we'll have the release of the EMA abstract as a headliner, so to speak.

Here is what I am thinking at this point-
Dr. Scarlett begins the call with the news of the EMA abstract, then basically says they can't say anything more about it.

He then gives an update of the Imetelstat Program (obviously!)... my guess is, everything is on track with the transfer from Janssen still set to occur by mid-year, the Phase III enrollment ready to begin by end of Q2, and decision of MF by end of Q3.
So my conjecture here is that the transfer from Janssen will not be complete by Thursday, and the no news news is that they still expect to be on track with their proviously proejected dates. I do hope the transfer is officially complete by Thursday though.

He then 'passes the mic' over to Dr. Rizo, and we finally get to hear from her. She'll comment briefly on the EMA abstract, and then perhaps go into MDS trial design, her current thoughts on MF, and maybe if we're lucky get thrown a bone about combo trials.

So I think it will be more of the same but will be refreshing to hear from Dr. Rizo. EMA abstract is a wild card based on the data, and the Janssen transfer I'm still on the fence on,,, but leaning to 'not quite yet but on track'.

Ryan
Posts: 38
Joined: Sat Jul 08, 2017 1:41 pm

Re: May 16th it is - Yet Another Day of Anticipation

Post by Ryan » Mon May 13, 2019 12:13 am

Well I see a lot of reads on my latest post - I suppose everyone just agrees with me :lol:

4 days we know... good luck all in this dawn of the next era for Imetelstat...

cheng_ho
Posts: 98
Joined: Sun Apr 03, 2016 11:27 pm

Re: May 16th it is - Yet Another Day of Anticipation

Post by cheng_ho » Tue May 14, 2019 3:56 pm

It's the EHA, not the EMA. One tries to cure heme diseases, the other protects pharma cartel profits... try to keep them straight ;)

Yes, this is the best-case scenario. IF the abstract suggests durable effectiveness, and IF we hear from Rizo instead of having the entire presentation in stuttervision, then the stock price should stagger back up to $2, at least briefly.

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: May 16th it is - Yet Another Day of Anticipation

Post by huntingonthebluffs » Wed May 15, 2019 5:24 pm

Short-term strangle buy in Geron (TheFlyOnTheWall)
THE FLY 9:30 AM ET 5/15/2019
Short-term strangle buy in Geron. The stock flat at $1.70 and 1.5K May 1.5 puts trade 5c along with 1.5K May 2 calls for a nickel. More than 3K trade in both strikes, which opens a May 1.5 - 2 strangle that expires in two days and expresses the view that shares could see an explosive move between now and Friday. Interestingly, 30-day implied volatility up 30% to 112.
xxxxxxxxxxxxxxx

Looks like others are following as the numbers are now at 3500 versus 1500.

Gwikley
Posts: 31
Joined: Thu Aug 30, 2018 9:05 pm

Re: May 16th it is - Yet Another Day of Anticipation

Post by Gwikley » Thu May 16, 2019 5:11 am

At some point in this progression it seems as though the left hand has no idea of what the right hand is doing. Rhetorical question is why is there such a disconnect between the stats offered by the sub-group of 13, and the FDA's apparent indifference to the same? OS is the standard. As it should be, once the side effect issues were resolved. Yet....it is just white noise to them. Maybe, just maybe, we'll be surprised some day.

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: May 16th it is - Yet Another Day of Anticipation

Post by huntingonthebluffs » Thu May 16, 2019 5:12 pm

May 16, 2019 Announcements and Press Releases and EHA Abstracts

May 16, 2019 6:00 AM EDT
Geron Continues to Build Senior Leadership of Its Development Team
http://ir.geron.com/news-releases/news- ... pment-team

May 16, 2019 8:00 AM EDT
Geron Provides Imetelstat Program Update
http://ir.geron.com/news-releases/news- ... ram-update

May 16, 2019 9:05 AM EDT
Geron Announces Two Presentations on Imetelstat at Upcoming European Hematology Association Annual Congress
http://ir.geron.com/news-releases/news- ... g-european

May 16, 2019
A Form 8-K has been filed with the United States Securities and Exchange Commission.
http://ir.geron.com/static-files/7e5db8 ... 5f9da7f8d4

EHA Abstracts:

TREATMENT WITH IMETELSTAT PROVIDES DURABLE TRANSFUSION INDEPENDENCE (TI) IN HEAVILY TRANSFUSED NON-DEL(5Q) LOWER RISK MDS (LR-MDS) RELAPSED/REFRACTORY (R/R) TO ERYTHROPOIESIS STIMULATING AGENTS (ESAS)
Author(s): Pierre Fenaux , David P. Steensma , Koen Van Eygen , Azra Raza , Valeria Santini , Ulrich Germing , Patricia Font , Maria Díez-Campelo , Sylvain Thepot , Edo Vellenga , Mrinal M. Patnaik , Jun Ho Jang , Laurie Sherman , Libo Sun , Helen Varsos , Aleksandra Rizo , Ying Wan , Fei Huang , Jacqueline Bussolari , Esther Rose , Uwe Platzbecker EHA Learning Center. Fenaux P. Jun 15, 2019; 267420

https://learningcenter.ehaweb.org/eha/2 ... imetelstat

FAVORABLE OVERALL SURVIVAL OF IMETELSTAT-TREATED RELAPSED/REFRACTORY MYELOFIBROSIS PATIENTS COMPARED WITH CLOSELY MATCHED REAL WORLD DATA
Author(s): Andrew Kuykendall , Ying Wan , John Mascarenhas , Jean-Jacques Kiladjian , Alessandro Vannucchi , Julia Wang , Qi Xia , Eugene Zhu , Faye Feller , Aleksandra Rizo , Jacqueline Bussolari , R

https://learningcenter.ehaweb.org/eha/2 ... imetelstat

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