Why does Geron's presentation show EU approval after FDA?

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

Why does Geron's presentation show EU approval after FDA?

Post by biopearl123 » Sun Jan 31, 2021 7:24 pm

That's a good question. Here is what is a little incongruent. 1. Geron's strongest data presentations have been at European conferences. 2. Geron's strongest voices have been predominated by European physicians (with the exclusion of Dr. Mascarenhas and Dr. Steensma from the US). 3. Orphan designation seems to open a potential door to MA in Europe, (foolishly) not the US. 4. Geron has received "approval" for pediatric orphan designation in the EU. It appears this is just a pro forma requirement that must precede MA since there is no path for utilization in the pediatric age group, but an apparent requirement for eventual MA. 5. As pointed out by Laz on YMB, the predominance of approval masters hired recently lean toward the European. 6. A path to MA exists in the EU but not in the US see below:

https://www.ema.europa.eu/en/documents/ ... ine_en.pdf

7. At this point the impressive longevity of the TI in a substantial number of patients has been established in the PII MDS study has has grabbed the attention of KOLs around the world.

8. Janssen has its head quarters in Europe, this is noncontributory and of historical importance at this point. 9. The Europeans have a heart and are much more inclined to allow compassionate use.

9. The profound effect of COVID on the worlds blood supply must at this point be recognized and be factored into the clear unmet medical need for Imetelstat. The FDAs failure to acknowledge this is profound. The EU likely to be more realistic.

10. While not strictly germane to the EU, Lazarus' posts on YMB have been particularly excellent and worth a read.

11. So why does Geron list EU approval, even in MDS, to follow FDA when it appears to be making great headway in the EU? Why? we do not know. That is the question.

Regards to all, bp

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

Re: Why does Geron's presentation show EU approval after FDA?

Post by biopearl123 » Sun Jan 31, 2021 7:36 pm

From the EU re MA:

"the benefit-risk balance of the medicine is positive". Check, just ask the KOLs
"it is likely that the applicant will be able to provide comprehensive data post-authorisation"--two PIIIs in progress, Check
"the medicine fulfils an unmet medical need"--huge transfusion requirement in LR MDS patients can be very positively impacted. World wide potential to help the blood banks all over the world and reduce iron overload. Check
"the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required". Check, KOLs agree side effects and risks manageable in competent hands.

Disease modification. Check.

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

Re: Why does Geron's presentation show EU approval after FDA?

Post by rccola335 » Sun Jan 31, 2021 9:21 pm

Janssen advertised for pricing managers in Europe - not US
if the EU grants MA - they will consult the FDA
Orphan was granted for MDS in July but in November the EU released another document about Orphan for MDS - timing was weird - whenever EU considers granting MA they review the Orphan again - is that what occurred?
a lot of options sold in June for 10 bucks for Jan 2021 - someone had inside info and felt there was a chance for MA - maybe they didn't get it
I sent Geron a letter about the Orphan for pediatrics last week but have not gotten a response as of yet

cheng_ho
Posts: 202
Joined: Sun Apr 03, 2016 11:27 pm

Re: Why does Geron's presentation show EU approval after FDA?

Post by cheng_ho » Mon Feb 01, 2021 8:37 pm

Statistically, that would be the normal order. The EMA is, on average, even slower than the US to approve drugs and vaccines.

For example, look at the vaccination rate by country. Most EU countries have barely started... and that's while the US gave everyone else a head start by not approving the AZN vaccine.

https://ourworldindata.org/covid-vaccinations

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