The difference between "may suggest" and "indicates"

Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Post Reply
biopearl123
Posts: 195
Joined: Fri Jul 20, 2018 5:13 pm

The difference between "may suggest" and "indicates"

Post by biopearl123 » Sun May 19, 2019 2:28 am

Musings on recent events. IR press releases and conference call: 1. The addition of more former Janssen employees to the team is important and in particular the statistician lends weight to the recent MF abstract. It is clear that the use of "Real World" matched controls takes us away from the prison of having to use the low dose arm as a comparitor rather than a placebo (no treatment arm in R/R study). For the first time a true statistical analysis (such as it is since there is no concurrent placebo arm but rather carefully matched controls) has allowed a p value to be derived and a significant Kaplan Meir curve to be presented that is not dependent on the low dose are for comparison. The resulting p value is very significant--not borderline but as close to definitive as one could hope given the study design. The FDA has given recent guidance as to the proper way to utilize a historic control. The Geron statistician is world class. No question that Geron plans to present this data to the FDA at the end of PII meeting with the intention of seeking approval. Following the meeting the FDA could rule within 60 days. Since Janssen is committed to provide drug to complete the ongoing studies, why do we need to ramp up ongoing manufacturing capabilities? Why indeed. Many of the authors on the paper were from Jansen indicating ongoing analysis and input from this team with continuing exodus to Geron to continue their work. An additional author included representation from Moffit/Florida the origin of the previous paper that gave us the 12-14 months OS previously, now amended to a solid 12 months with the treatment group exceeding 30 months. We should have bone marrow data and molecular marker data at EMA also, just what the FDA says they want to support approval. So we have proof of MOS and molecular markers and hopefully more bone marrow data with longer time to evaluate spleen and symptoms (not mentioned in abstract). What is implied is the patient drop out was a mistake and the drug was not continued long enough to pick up delayed responders. On to MDS, more 8 week TI and 24 week Ti with late responders going the party. How about those early drop outs? Same problem. Also more evidence for molecular responses and presumably more bone marrow data (not present in abstract but hopefully presented at meeting.). So to the conclusion: for the first time we have not seen the hedge of "may suggest potential effect on the malignant clone" to "indicates an effect on the malignant clone. Much stronger language for a very desirable and perhaps unique effect of this drug. We shall see. The proposed PIII protocol on clinical trials site had been largely untouched for many years, perhaps the trial will be refined in a good way to shorten time to end point analysis. We shall see. All thoughts welcome. I am voting my shares in favor. Regards and best wishes to all, bp

cheng_ho
Posts: 99
Joined: Sun Apr 03, 2016 11:27 pm

Re: The difference between "may suggest" and "indicates"

Post by cheng_ho » Tue May 21, 2019 2:43 pm

The issue with Janssen as an imetelstat supplier is cost, not quantity. Any commercial supplier would give a better deal (kind of nasty of Janssen to charge high prices for their stockpile of a drug that they are just discarding anyway, but there it is).

Again, it's the medical organization "EHA", not the regulatory/cartelization organization "EMA".

muskateer
Posts: 5
Joined: Thu Aug 23, 2018 8:33 pm

Re: The difference between "may suggest" and "indicates"

Post by muskateer » Fri May 24, 2019 5:19 pm

Are you "namebackwards"? You write with the same depth and detail.

biopearl123
Posts: 195
Joined: Fri Jul 20, 2018 5:13 pm

Re: The difference between "may suggest" and "indicates"

Post by biopearl123 » Sat May 25, 2019 1:38 am

I am not sdraw but you honor me with the comparison bp

Secret Third Arm
Posts: 16
Joined: Tue Aug 28, 2018 3:26 pm

Re: The difference between "may suggest" and "indicates"

Post by Secret Third Arm » Sun May 26, 2019 2:37 pm

Cheng_ho/telomerase/Bill Walker,

That is a hilarious interpretation of what has transpired regarding the purchase of Imetelstat drug from Janssen. Without any way of knowing the quantity purchased there is no way to determine the cost paid and if it was higher than available elsewhere. Yet you continue to 'soft bash' this company and drug with your pseudo-intellectual postings in the hopes that you will influence the less well informed.

Geron clearly stated that they were not just purchasing finished drug product but also the means of production as well. If commercial oglio companies can produce Imetelstat then that means one of two things: 1) There is some special component needed and Janssen (now Geron) supplies them with that, or 2) Janssen/JNJ actually purchased some speciality equipment with the thought of making Imetelstat in house and now Geron owns that.

In either case Geron's Vice President of Manufacturing has deemed it prudent to purchase this stockpile. The case could be made that having a stockpile of drug on hand for the Phase 3 MDS trial is a smart move. Afterall, if the product exists and has passed quality control then why start over by making more? That would simply slow the trials down. Additionally, some believe (as I do) that MF may get approved based on historical data.

If true, then the drug would be commercially available very soon, and having a stockpile to supply those patients as well as run a confirmatory Phase 3 is well advised. Heck, if that happened I think there might be additional demand for the drug right away in off label use for MDS. I also think that a demonstrable stockpile of Imetelstat that is already manufactured and has passed quality control will be an important aspect of Geron's presentation of Imetelstat to either the EMA or FDA for approval.

-Bridge to sell.

bucbeard
Posts: 25
Joined: Wed Jul 25, 2018 12:30 am

Re: The difference between "may suggest" and "indicates"

Post by bucbeard » Sun May 26, 2019 3:12 pm

^^^This ^^^

Thank you for sharing BTS

cheng_ho
Posts: 99
Joined: Sun Apr 03, 2016 11:27 pm

Re: The difference between "may suggest" and "indicates"

Post by cheng_ho » Thu May 30, 2019 2:43 pm

>"MF may get approved based on historical data."

Yes, that has always been a major hope here (maybe the principal hope, given the competition and timeline in MDS). But it can't happen before the company at least talks to the FDA in 2020. There is plenty of time to order a short oligo from a commercial supplier.

IMO it is really pathetic of Janssen to charge its victim for something that is completely useless to Janssen. I guess it does tell us that they never plan to have any dealings with Geron again, as they care nothing for good will.

Post Reply