Additional thoughts

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Additional thoughts

Post by biopearl123 » Sun Jun 07, 2020 12:19 am

Its pretty obvious at this point that:

1. Geron has a unique drug that has been shown to A. prolong life and reverse fibrosis in MF and B. Cause durable transfusion independence in MDS. This seems pretty certain to the extent one can comment on phase two data. The value of two active PIII studies is substantial as is the potential future market.

2. Development in AML, PV, ET seems a certainty, just a matter of when.

3. Approval is years off.

4. New biotech drug entities are few and far between.

5. the relationship with the FDA is favorable and there is a path of approval if the PIIIs go ok

6. Geron has been very circumspect about the extent of their IP in other areas and this would very likely add significant value to the company for a purchaser.

7. There is probably still some favorable carry forward tax advantages that add value we don't see.

8. The management, manufacturing and R and D team is first class.

9. Geron plans to become the dominant company in the treatment of myeloproliferative diseases.

10 The telomere is an essential part of cancer biology and future therapies remain to be defined especially in the unmentioned area of other cancers. This may represent untapped value. The caveat is that J and J didn't seem to think so but some of Geron's IP is related to other telomerase directed therapies. Some of this remains inchoate.

11. The upcoming EHA presentations and following KOL presentations will likely result in a public relations blitz to highlight the current and future value of this company.

12. Some large pharma would be crazy not to find a way to buy this company but because of all of the above valuation would probably be a very complex process.

13. Dr. Scarlett and his management team have an intimate knowledge of just what the value of this company actually is, and will be formidable negotiators when the time comes.

14. There is a high likelihood of acquisition at some point. The longer a potential acquisitor waits, the greater the value of the company and the higher the price.

The above are my thought only. Please feel free to challenge or add to them. Best regards to all. Stay healthy. bp

rccola335
Posts: 305
Joined: Sat Sep 28, 2019 10:00 pm

Re: Additional thoughts

Post by rccola335 » Sun Jun 07, 2020 1:11 am

the team is built for approval and they have the cash for approval - i do not seeing them interested in selling until a drug is approved - a partnership is another story
Very interesting thing pointed out on Seekingalpha by Gerononeshotongoal - one of the investment Groups that bought just under 10 percent of Geron -New Enterprise Associates has hired Scott Gottlieb to their team - things that make you go hmmm

kmall
Posts: 753
Joined: Thu Mar 21, 2019 3:57 pm

Re: Additional thoughts

Post by kmall » Sun Jun 07, 2020 7:09 am

Hmmmmm.......I think I Tweeted that guy a dozen times or more when he was FDA Director about Imetelstat and the fact that MOS is 3x that of the next BAT.... Hmmmmmm???

Wonder how many patients he could have helped between now and then.........Hmmmmmm???

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Additional thoughts

Post by biopearl123 » Sun Jun 07, 2020 8:51 am

Kmall, it is shameful that the FDA overlooked the opportunity to make Imetelstat the RWD test case. Especially with molecular end point data.available also. Especially with hard evidence for fibrosis reversal. Especially with the ethics of having a no treatment control arm at this late stage in the disease. There is plenty of RWD data out there that could have continued to be collected. A shonda. bp

kmall
Posts: 753
Joined: Thu Mar 21, 2019 3:57 pm

Re: Additional thoughts

Post by kmall » Sun Jun 07, 2020 2:26 pm

Absolutely Andrew! My faith in the FDA has been shaken. Through their own "Clinical Trial Endpoints For the Approval Of Cancer Drugs" - December of 2018 - https://www.fda.gov/media/71195/download

Pg. 7 - "Overall survival is defined as the time from randomization until death from any cause and is measured in the intent-to-treat population. Survival is considered the most reliable cancer endpoint, and when studies can be conducted to adequately assess survival, it is usually the preferred endpoint. This endpoint is precise and easy to measure, documented by the date of death. Bias is not a factor in endpoint measurement. Survival improvement should be analyzed as a risk-benefit analysis to assess clinical benefit."

......."SURVIVAL IS CONSIDERED THE MOST RELIABLE CANCER ENDPOINT" !!!! - FDA Dec / 2018

This was published under Dr. Gottlieb, and two weeks after ASH 2018 results were revealed. With 2-3x the OVERALL SURVIVAL of BAT - why are we even in P3 concerning an Unmet need life saving drug? At one point I tried to figure out how many patients died from MDS here in the US every day - and that was basing my figures on a patient population of 60,000...........we all know from my "Go Big or Go Home" series last week that those numbers are most likely 2-3x that......I provided numerous links to evidence of this throughout all 6 posts.


Here is the post on mortality rates for MDS from the YMB dated 2/8/2019 -

https://onlinelibrary.wiley.com/doi/ful ... /ajh.23671

"Trying to see if I'm in the ballpark here with MDS mortality rates. What I could find was a study from 2008 - 2011. I came up with out of 1,056 patients diagnosed - 41% were listed as MDS being the underlying factor for death / year ( this is outside of the US - the US is higher and so is the overall number now since this study is 8 years old and patients diagnosed have increased due to longevity in age and MDS being more frequently diagnosed - there is now a correlation of Chemo and MDS/AML being linked).

So here's my rough breakdown -
1,056 patients deceased
41% MDS underlying cause = 432.96 / year deceased total
432.96 / 365 days per year = 1.186 patients/day dying from MDS
1.186 / day - that's over 79 patients since ASH 2018 results were revealed. ( Veneto Region in Italy )

Again US is higher, and study is 8 years old. The link is above. Thoughts and please correct me if I misinterpreted this study or did "fuzzy" math - wasn't always my strongest academic. Thanks! -Kmall

Side note:
* Keep in mind the above formula is from the Veneto Region (North‐Eastern Italy, about 4,900,000 inhabitants)
same formula - US population (325 million - 2017) about 3.003 patients / year deceased with MDS as underlying factor
3,003 / year = 8.277 patients per day?

Base # is 5.5 diagnosed with MDS / 100,000 ( Veneto Region - Italy ) ( * US - would be higher )
- Same formula of 41% of the total using US population of 325 million"

...........I was only able to find a conclusive study on mortality rates in Italy so that's what I based the above projection on. I never did elicit a response from anyone concerning my breakdown. I'm fairly certain its close however. So since the FDA and Dr. Gottlieb published the update for Clinical Trial Endpoints in 2018 - 18 months ago - approx. 4,500 more patients have died here in the US alone. How many of those patients would still be here if Imetelstat was available given the FDA "Clinical Trial Endpoint" Guidance of 12/2018???

Even Dr. Scarlett weighed in on concerns regarding side effects during Needham 2019 - 6 months after that publication saying -

"They understand how to manage the drug in regards in cytopenias" - Dr. John Scarlett - Needham 2019

If you had a fatal disease, I'm fairly certain most side effects would take a back seat over OS.

Let's hope that Dr. Gottliebs influence can finally help the patients who desperately need this drug NOW and 18 months ago !!!
I have a lot I can elaborate on in that department, however, it is my hope that as a cancer survivor himself he does the right thing this time despite any financial incentives. -Kmall

cathy
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Joined: Thu Jun 04, 2020 8:14 pm

Re: Additional thoughts

Post by cathy » Sun Jun 07, 2020 3:25 pm

When Gottlieb was FDA commissioner I wrote him several times about allowing my husband to try Vicinium for NMIBC. This drug was developed by Sesen and had been through P3 successfully and was next having to go through a lengthy P4 and BLA approval. Gottlieb said when he became head of the FDA he was going to combine all the Phases into one step and develop new criteria based on need to cut the time when the drugs could be used and saved lives. I wrote him repeatedly, inspired by the Sarepta DMD mothers but he never responded. He left the FDA having done nothing except maybe for vaping restrictions and then he joined the boards of Big Pharma and CNBC for huge salaries. He also talked down COVID in early march for 2 weeks for reasons that are suspicious. I do not trust him or like him.

rccola335
Posts: 305
Joined: Sat Sep 28, 2019 10:00 pm

Re: Additional thoughts

Post by rccola335 » Sun Jun 07, 2020 4:15 pm

i think we will be approved and it won't be 4-5 years like someone on YMB posted - my concern with the MF phase 2 was always the number of people who stopped because they weren't getting the spleen response - did this taint the study to much to consider AA? - also the Italian study released right before the continuation decision did not help
My feeling always was it should be strongly considered due to the hopeless prognosis of these patients and the potential benefit.
Janssen advertising for a pricing manager for Imbruvica and Imetelstat (AML and MDS) gives us the impression they felt they were close to approval in Europe - interesting times ahead

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Additional thoughts

Post by biopearl123 » Sun Jun 07, 2020 6:55 pm

ruccola, Unless some beacon of reason takes over at the FDA, Dr. Scarlett said (as an estimate--baring complication) to look for approval in early 2024. That's about 4 years from now. I suppose if the MDS study expands and becomes fully enrolled, top line data might be available before mid 2022. In the meantime consider this. I was going to add regarding additional thoughts that several thousand articles had been written regarding the telomere and telomerase as an off hand estimate. I was wrong. When I researched it the number is more like 326,000 citations. Geron's IP is pretty extensive here and Dr. Scarlett is reluctant to elaborate for competitive reasons. Interesting. Also remember there are small royalty agreements in place with the companies that continue stem cell related research, OPC, retinal therapies, dendritic cell driven therapies etc that Dr. Scarlett off loaded. There is some value buried here too. Its going to get interesting well before the approval timeline such as it appears to stand now. Conclusion? This is a very undervalued stock. bp

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