A question for the FDA

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biopearl123
Posts: 409
Joined: Fri Jul 20, 2018 5:13 pm

A question for the FDA

Post by biopearl123 » Sun Jul 26, 2020 11:02 pm

Recently an article in the Wall Street Journal highlighted a list of co morbid conditions that predisposed to death should a patient get COVID. The data was taken from the unimpeachable journal "Nature". The highest risk co morbidities list was headed by blood and bone marrow cancer. Higher risk than diabetes, higher risk than heart disease, higher risk than hypertension, higher risk than any of them which I won't list here. That's understandable. After all, the immune system is inexorably linked to the bone marrow (spleen, lymphatic system notwithstanding). A fibrotic barely functional bone marrow will do little to help fight COVID-19. Either will anemia. Either will a spleen that has been enslaved to work overtime making shadow cells trying to do a job formerly tasked to strong, healthy cells. Even if the bone marrow could be turned toward normalcy but not completely normalized one might have a fighting chance restored. Given that 1000 patients are dying a day now from COVID (think 1 and 3/4 Jumbo jets crashing each day) one might think something could be done for the highest risk group. Given that the nations blood supply has been strained like never before in peacetime, or perhaps during the AIDS epidemic, one would think that something could be done. Given that more patients have received Imetelstat safely (>600), way more than have received any experimental COVID vaccine (with approval within months), one would think something could be done. Something could be done. Yes, something could be done. What might that thing be? Well the FDA could start by listening to the Key Opinion Leaders in the field of hematologic diseases who know what that something is. Kamall, wherever you are this situation cries out for you. You have the experience given your "world travels" to carry the torch. What about the rest of you? Carry the torch! We are facing a national catastrophe, lets at least help those whom we can help now, well before a vaccine becomes available. And so to my question for the FDA: What in God's name is wrong with you? Oh, I understand. I didn't phrase it well. Let me try again: WHAT IN GOD'S NAME IS WRONG WITH YOU?. bp

kmall
Posts: 56
Joined: Thu Mar 21, 2019 3:57 pm

Re: A question for the FDA

Post by kmall » Mon Jul 27, 2020 4:11 am

I had tried posting here several weeks ago before leaving FL for NY.....somehow I was locked out via my password - had to create a new one. Traveling by sail has been an incredible experience as a "live aboard".....dodged a number of electrical storms off the FL coast heading north and was able to anchor off Cumberland Island, GA for a few days to rest up before continuing. Highly recommend a visit for anyone on this forum who has never been there - my first time. Other highlights so far have included Winyah Bay, SC and Cape Lookout, NC. We're currently in the Chesapeake waiting to get hauled out for a few unexpected repairs with our saildrive.....a 3 week wait is now the norm in the marine industry these days due to an overwhelming demand for boats with the Covid crisis we're in the midst of. Enough of the journey on my end.....on to things Imetelstat since the last time I checked in.

I found the possible Designation of Orphan Status by the EMA PR earlier this month very encouraging. As I stated several months ago, Gerons focus looks to be geared towards EMA approval first. Sharon McBains role, new P3 locations and the emphasis placed on an Ex-U.S. partnership for commercialization all seem to point in that direction. As well the recent abstract out of Japan posted on the YMB about a month ago (by Kanger - I believe) - 6/22/2020 - Short-term treatment with Imetelstat sensitizes hematopoietic malignant cells to a genotoxic agent via suppression of the telomerase-mediated DNA repair process

https://www.tandfonline.com/doi/abs/10. ... ode=ila120

Stellar find Roo!! - and totally out of left field....and again I made a prediction here back in May/June that Eiasi was a frontrunner for a partnership consideration.....I'm sticking to my guns on that one and as I stated back then it's pure speculation on my part with a dash of first hand knowledge from the company indirectly....that's all I can say, but as we now know from the 6/22:abstract there is a STRONG Japanese interest in Imetelstat. It wouldn't surprise me to see approval first in Japan as they would see the benefit of alieving transfusion burden patients amidst this pandemic and the strain it places on blood supply as Andrew, our estute moderator has stressed since the beginning of the global Covid crisis.

Lastly, and probably most importantly, I find the constant dump on Dr. Scarlett and management on other forums to be a rouse by mainly short interest to distract attention on what an incredible job they have done even before the Janssen walk. Getting 2 Phase 2 clinical trials completely funded and then controlling 100% ownership afterward, and seamlessly harvesting the lead drug developer and her team away is just flat out BRILLIANT!!! Those who speak ill of Dr. Scarlett will be singing his praises once approvals come rolling in and the SP finally gets the traction it so richly deserves. All the best to you Andrew, the Imetelchat board, team Geron and of course all of those patients currently enrolled in the P3 clinical trial. Please stay safe and enjoy your summer as best as you can. -Kmall

biopearl123
Posts: 409
Joined: Fri Jul 20, 2018 5:13 pm

Re: A question for the FDA

Post by biopearl123 » Mon Jul 27, 2020 6:17 pm

Hi Kamall, sorry you had trouble posting before, as you know we have glitches with this site for reasons discussed previously. It was great to hear from you, I was afraid you had been blown off course and ended up on an island previously only inhabited by a FedEx guy. Thank you for your research and the great points you have contributed. I have to modify my previous post since Moderna has started a 30,000 patient trial (50-50 randomization) so my former statement about the numbers of people receiving a potential vaccine is no longer correct. Clear sailing and may the wind always be at your back. bp

biopearl123
Posts: 409
Joined: Fri Jul 20, 2018 5:13 pm

Re: A question for the FDA

Post by biopearl123 » Mon Jul 27, 2020 6:57 pm

Sorry about the Kamall, kmall, I know you better than most of the other posters but my spell check does not. bp

cheng_ho
Posts: 144
Joined: Sun Apr 03, 2016 11:27 pm

Re: A question for the FDA

Post by cheng_ho » Mon Jul 27, 2020 8:58 pm

Don't vent here, tell the FDA themselves:

https://twitter.com/US_FDA

Of course they're too busy explaining why they banned PCR tests for SARS-CoV-2 (except for the non-working CDC test) until Feb 29, and STILL don't any pharma to release info on off-label drug use for coronavirus.

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