ADCOM

[KTArsenal]

LWS:

Aside from your poorly constructed ADCOM/imetelstat speculations, it's also in poor taste to create conspiratorial woo about WWIII in an online forum that's been devoted and dedicated to a therapy that targets telomeres to extend the lives of cancer patients and potentially extinguish the cancer itself.

WWIII will extinguish the lives of a very large percentage of humanity, regardless of a human disease, like cancer.

**I edited these paragraphs because I sometimes allow my negative emotions to write or speak in an incomplete or incoherent manner. My apologies.**

[LWS]

KT --- My primary concern is Imetelstat being placed on the Oncology ADCOM agenda at the meeting (after Nov. 16) when it is scheduled. I believe that once the medical experts and KOLs are heard in this public forum, there will be no doubt about Imetelstat being a priority medicine that is needed now by many.

The EAP is an intermediate solution that will help some immediately and provide additional and current data, but it is only a band aid. Imetelstat needs to be recognized by both the medical world and the investment world as the "remarkable, durable, and compelling medicine" that it is for blood cancers and beyond.

Time is of the essence.

[LWS]

Unanswered Question:

Please tell me: What am I missing medically about Imetelstat's successes? The Oncology ADCOM will only get good news, in my opinion.
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Previous:

bp & kmall --- As I stated, there seems to be no important negatives (that I am aware of) from medical experts or KOLs concerning Imetelstat (please correct, if wrong).

[LWS]

ADCOM and the Timeline

All indicators that I can find indicate that Imetelstat is a superior and unique medicine that is needed now. I have asked for the important negatives, and none have been posted. I have to conclude that there are none and the NDA approval will smoothly follow the EAP, which is now available.

We are waiting for the Imetelstat Oncology ADCOM meeting to be scheduled. The evidence supporting Imetelstat looks to be overwhelmingly positive. The timeline, we hope, will be shortened, but the NDA approval (very long in coming and very needed) seems to be assured.

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WEP CLINICAL ANNOUNCES PARTNERSHIP WITH GERON CORPORATION FOR AN EXPANDED ACCESS PROTOCOL FOR IMETELSTAT

WEP Clinical (WEP) is pleased to announce a partnership with Geron Corporation (Geron), a late-stage clinical biopharmaceutical company, to make investigational drug, imetelstat, available to patients through an Expanded Access Protocol (EAP).

EAPs offer an important potential pathway for patients with serious or immediately life-threatening diseases to gain access to investigational medicines for treatment outside of clinical trials, when no other viable treatment options are available.
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Previous (for reference):

Obviously, it is an overwhelming combination of “conclusive evidence”:

1/ The successful phase 3 trials
2/ The conferences (EHA, ASCO leading to ASH2023)
3/ The experts (KOLs, Webinars, MD Anderson, etc.)
4/ Transfusion independence, survival time, safety, uniqueness, fatigue factor
5/ Fast track, orphan drug status, EAP
6/ Disease modification, kills cancer stem cells
7/ Combination potential and synergies
8/ Patients’ immediate and unmet needs
9/ The medical journals (Lancet and others)
10/ NDA submitted, accepted and near approval (timeline flexible)

The ADCOM and the FDA will not ignore the obvious.

[LWS]

Everything for Imetelstat now is phase 3 successful, or in advance clinical studies including 2 ways to kill cancer stem cells. No negative news at all for the ADCOMs to consider. The Oncology ADCOM needs to be put on the schedule for Imetelstat (probably after ASH2023) post haste. Everything on the medical side appears to be very positive. (correct if I am missing something)

[biopearl123]

What you are missing is that no amount of wishful thinking will change the FDAs schedule.

[LWS]

bp & Kmall & others--- It appears that we all agree that Imetelstat has 'crossed all of the medical hurdles and tests' to transition from the EPA (in place) to the NDA approved. The discussion has come down to the scheduling of the Oncology ADCOM meeting featuring Imetelstat and John Scarlett's views on the business going forward ("Imetelstat is bigger than all of us"). Nov. 2 (tomorrow) will tell us something, but will it be useful and important information for investors? We will know by this time tomorrow.

Pleasant dreams.

[biopearl123]

Where you see agreement, I can assure you there is no agreement and won’t be until the FDA says there is.

[KTArsenal]

Yep.

Is SCOTUS untouchable? Is the Presidency untouchable? Are Senators and Representatives largely untouchable? How about the military industrial complex, specifically the Pentagon, are they largely untouchable? The Justice Department, the FAA; the Health and "Human" services department, the FCC. They're all basically untouchable and create timelines that best suit themselves, i.e. money, contracts, PACs, and billionaire sponsorships, (but really they're election/re-election campaign donors, just as we've been programmed to parrot).

The FDA isn't exempt from being another federal government office that's basically untouchable, which can operate on their own timeline and to hell with public scrutiny. They're funded by tax dollars and tax dollars are as certain as death from an AML diagnosis.

[LWS]

Where you see agreement, I can assure you there is no agreement and won’t be until the FDA says there is.--- from bp

The FDA isn't exempt from being another federal government office that's basically untouchable, which can operate on their own timeline and to hell with public scrutiny. --- from KTArsenal

It appears that we all agree that Imetelstat has 'crossed all of the medical hurdles and tests' to transition from the EPA (in place) to the NDA approved. The discussion has come down to the scheduling of the Oncology ADCOM meeting featuring Imetelstat and John Scarlett's views on the business going forward ("Imetelstat is bigger than all of us") --- from LWS

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I believe that most (if not all) on this board, based upon what we know and assuming no medical fraud, believe that Imetelstat is at least a very good blood cancer medicine worthy of the EAP that the FDA has granted, and should get priority consideration.

The discussion now seems to be about weaknesses in the ADCOM Oncology scheduling, the FDA in general, and John Scarlett's leadership. We will see what tomorrow brings.

[KTArsenal]

If imetelstat in MDS was given priority review, Dr. Scarlett would be hailed as a clinical trial genius, and the Janssen divorce would've been completely forgotten about.

As it stands today, Dr. Scarlett was left at the altar by both JandJ and the FDA, and he's extremely unhappy with those sophomoric results. Compiled CT data should have allowed for priority review, but alas, the FDA is here to f*ck cancer patients with their chemo ports right in their asses

[KTArsenal]

Cheers

[biopearl123]

KT, to be sure, John can’t be pleased with the FDA and neither should we, or doctors, or patients, or lenders, (oh wait they get more months of interest as the loan payback is delayed) or Wall Street (oh wait, they get to issue more stock and take large fees). So with some exceptions, no one is happy. As we have stated, four more months of carrying costs probably amounts to 40 to 50 M. We can’t blame John for this, we know they applied for priority review and were rebuffed. The FDA however might not have done their homework perhaps buying more time, of which they have had plenty by the way. To Kmall’s point, perhaps preliminary AML data will also be presented to the agency but I just don’t see it, they are too busy telling us that those cold meds never worked anyway. (Let’s see, would that be 30 years and how many misspent dollars too late?). Unless John announces a partner tomorrow, the financial news will not be good, there is just too much drain on the finances and an infusion will certainly be needed. Where that comes from might be more loan money, a partnership but more likely a raise. The scientific news on the other hand will probably be quite good and ASH has potential to be exciting. Every year I predict a plenary session for Imetelstat. Every year I have flubbed it. So this year my prediction is no plenary session. Let’s see if that works. Let’s hope Drs. Bruedigam and Lane knock it out of the park at ASH. Regards, bp

[LWS]

ADCOM will be Scheduled

KT, to be sure, John can’t be pleased with the FDA and neither should we, or doctors, or patients, or lenders, (oh wait they get more months of interest as the loan payback is delayed) or Wall Street (oh wait, they get to issue more stock and take large fees). So with some exceptions, no one is happy. As we have stated, four more months of carrying costs probably amounts to 40 to 50 M.

We can’t blame John for this, we know they applied for priority review and were rebuffed. The FDA however might not have done their homework perhaps buying more time, of which they have had plenty by the way. So this year my prediction is no plenary session. Let’s see if that works. Let’s hope Drs. Bruedigam and Lane knock it out of the park at ASH. Regards, bp

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bp --- For now, let’s take the positive view:

1/ The ADCOM Oncology critical meeting will be scheduled after ASH (in Dec. or Jan.)
2/ That meeting will go very well, with overwhelmingly positive support for Imetelstat
3/ The FDA, with many considerations, has not done sufficient homework and is trying to catchup
4/ John is doing his best to get Imetelstat over the finish-line
5/ JNJ and AbbVie both know Imetelstat very well, and are important parts of its future (IMO)
6/ Geron’s extreme price swings are market forces that have nothing to do with Imetelstat’s medical successes and potential going forward
7/ There are no known important medical negatives
8/ NDA approval is assured with the EAP in place and operational
9/ ASH2023 will be very positive for Imetelstat (also other conferences and publications)

[biopearl123]

LWS, enough. We have no idea when the ADCOM meeting will be scheduled. Much more likely to be scheduled much closer to June date. Wishing and repetition does not and will not make it so. You are getting very close to requiring the red pencil.

[Zhears]

Looking at the past 3 or so years of meeting dates, a Feb date for them to restart seems more probable.
That of course doesn't mean it would be on the agenda then and could be later.

All seems positive and I think we have all learned patience by now.

[LWS]

ADCOM Oncology Meeting for Imetelstat (sooner or later? --that is the question now)

Geron’s extreme price swings are market forces that have nothing to do with Imetelstat’s medical successes and potential going forward—from LWS

We have no idea when the ADCOM meeting will be scheduled --- from bp

All seems positive and I think we have all learned patience by now. --- from Zhears

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There will be an ADCOM oncology meeting for Imetelstat. We do not know when. My opinion is that it will be sooner than later, but no one knows, at this point in time. There are many moving parts, and it all has to be sorted out.

As Zhears says: All Positive and Patience Now

[biopearl123]

JS says ADCOM 4 to 6 weeks pre PDUFA

[LWS]

ADCOM (user fees or not necessary?)

“The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products. Since the passage of PDUFA, user fees have played an important role in expediting the drug review and approval process.”

Dr. S. seems to be saying there may not be a review. It could get cancelled and I would hope that means moved to the approval stage. --- from jayfish101

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bp --- There seems to be a possibility that the data and expert testimony are already so overwhelmingly positive (trials, KOLs, publications, conferences) that the ADCOM could be skipped and Imetelstat could go directly from EAP operational to NDA approved rather quickly.

Also, are PDUFA (user fees) being collected? I suppose both are possible (user fees & no ADCOM). The trend appears very positive.

[LWS]

Timeline

ODAC (Oncology ADCOM) should be able to quickly acknowledge the overwhelming demand and need for Imetelstat that is already a proven medicine (trials, KOLs, conferences, publications, EAPs). Unless there is some unknown medical negative, that no one knows about, that is suddenly exposed, everything should happen very quickly after ASH2023.