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GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company's Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1
Since we're looking at these things today. A 3m cap co, with a (S) and (N) approach that they think will require infrequent modifications or updates.
https://finance.yahoo.com/news/geovax-receives-barda-project-nextgen-110000120.html
I was today years old when I first learned about this co.
Biotech Bankruptcies Table (from #msg-174619426) Sorted by Date
iHub
Corp Date Reference
DMTK 6/24 #msg-174619409
IGXT 5/24 #msg-174439828
ACOR 4/24 #msg-174156166
AMPE 4/24 #msg-174111257
EIGR 4/24 #msg-174151841
BTTX 3/24 #msg-174037486
GMDA 3/24 #msg-174125313
NBSE 3/24 #msg-174119874
DMK 2/24 #msg-173773814
LIAN 2/24 #msg-173835088
MACK 2/24 #msg-173845049
NSTG 2/24 #msg-173773766
NVIV 2/24 #msg-173755991
NVTA 2/24 #msg-173844970
OBSN.SW 2/24 #msg-173937364
SIEN 2/24 #msg-173834941
ARAV 1/24 #msg-173646720
ATHX 1/24 #msg-173589749
AXLA 12/23 #msg-173374718
LMDX 12/23 #msg-173530663
TOMDF 12/23 #msg-173490278
ALPIX.PA 11/23 #msg-173275218
CWBR 11/23 #msg-173138450
NEXI 11/23 #msg-173152495
TMBR 11/23 #msg-173254229
INFI 10/23 #msg-172941539
PROMO.ST 10/23 #msg-173007859
RVLP 10/23 #msg-173007859
BCART.BR 9/23 #msg-172903024
FRTX 9/23 #msg-172854853
HSTO 9/23 #msg-172847239
HGEN 7/23 #msg-172432338
NMTR 7/23 SEC link
NOVN 7/23 #msg-172361873
VRAY 7/23 #msg-172361873
ONCR 6/23 #msg-172037432
ONCS 6/23 #msg-172145325
SRGA 6/23 #msg-172201878
ATNX 5/23 #msg-171913749
IMV 5/23 #msg-171814610
PEAR 4/23 #msg-171639648
PLXP 4/23 #msg-171677346
CDAK 3/23 #msg-171544942
MRV.TO 3/23 PR link
SCLX 2/23 #msg-171193757
SRNE 2/23 #msg-171193757
ASP.TO 1/23 #msg-171046860
CALA 1/23 #msg-170898055
CLVS 12/22 #msg-170599077
OTIC 12/22 #msg-170737355
QTNT 12/22 #msg-170676963
SIOX 12/22 #msg-170699458
PHAS 10/22 #msg-170272758
ALNA 9/22 #msg-169875553
CRXT 9/22 #msg-170229149
ENDP 8/22 #msg-169707980
CBIO 6/22 #msg-169273606
LBPS 6/22 #msg-169255625
ZSAN 6/22 #msg-169035970
GNCA 5/22 #msg-168957883
KLDO 4/22 #msg-168491485
ORPH 3/22 #msg-168169591
LHDX 2/22 #msg-171275021
RUBY 2/22 #msg-171270235
ODT 3/21 #msg-162706983
MNK 10/20 #msg-158843178
VVUS 7/20 #msg-156752080
EYES 6/20 #msg-156388471
SPHS 5/20 #msg-155712447
VLRX 2/20 #msg-153741993
NVLN 1/20 #msg-153111867
RVALL 1/20 #msg-153358221
MLNT 12/19 #msg-153074747
SNNA 9/19 #msg-151196707
INSY 6/19 #msg-149302493
AKAO 4/19 #msg-148227772
MBVX 3/19 #msg-151985211
ARDM 2/19 #msg-146903332
IMNP 2/19 #msg-146936897
PTX 2/19 #msg-146937356
SGYP 12/18 #msg-145394802
ARLZ 8/18 #msg-142824112
ROSG 6/18 #msg-141797330
BIOA 5/18 #msg-140549553
OREX 3/18 #msg-139213097
ARNI 12/17 #msg-137120846
DXTR 12/17 #msg-136829445
PZRX 12/17 #msg-136794351
IMMG 8/17 #msg-134305213
ROKA 8/17 #msg-133945967
ILIU 7/17 #msg-133264435
NVDL 2/17 #msg-128923029
RCPI 8/16 #msg-127560117
EPRS 7/16 #msg-123687350
DDXS 6/16 #msg-123229557
BIND 5/16 #msg-122328088
NRX 5/16 #msg-122331475
KBIO 12/15 #msg-119489701
Egenix 1/15 #msg-109921347
BAXS 11/14 #msg-108147336
DNDN 11/14 #msg-108004147
SIGA 9/14 #msg-106313111
RXPC 7/14 #msg-104103329
AFFY 6/14 #msg-103663749
SVNT 10/13 #msg-92997648
PYMX 4/13 #msg-86313192
BVTI‡ 3/13 #msg-85440257
Inspiration 10/12 #msg-81024196
GNTA 8/12 #msg-78123007
KV.A 8/12 #msg-78203130
Biolex 7/12 #msg-77324773
HEMA 4/12 #msg-74167597
NRGX 3/12 #msg-73415156
TDLP 6/11 #msg-64744114
ADLS 5/11 #msg-62813901
NMTI 4/11 #msg-62251315
MIPI 12/10 #msg-57646943
CJB.TO 7/10 #msg-52557510
MBRK 4/10 #msg-49658072
ANSV 1/10 #msg-45161615
TLCV 12/09 #msg-44751578
VION 12/09 #msg-44654555
ALTU 11/09 #msg-43509933
DCGN 11/09 #msg-43629379
AMB.TO 8/09 #msg-40145970
CLSC 8/09 #msg-40685152
BPUR 7/09 #msg-39629524
Epix† 7/09 #msg-39900524
OSCI 7/09 #msg-39511719
Isolagen* 6/09 #msg-38746197
AGIX 1/09 #msg-35019458
ARTE 12/08 #msg-33895436
CHKT 12/08 #msg-33949508
Introgen†† 12/08 #msg-33947783
MIIS 11/08 #msg-33720220
REX 11/08 #msg-32189097
GTOP 9/08 #msg-32249160
TPPH 2/08 #msg-26765260
VRA 10/07 #msg-18053275
Re: Table of Biotech Bankruptcies
I don't plan to maintain two tables, but it's pretty easy for anyone to copy the table text and sort it by date. I'll do this once in the next post.
Biotech Bankruptcies: Sorting list by date would_add_insight to how the market is doing.
If you don’t mind doing both from time to time.
LGND receives $2M milestone payment_for_FDA_approval_of Capvaxive (#msg-174614515):
https://www.businesswire.com/news/home/20240618130919/en
I thought this amount might be somewhat larger.
Recent Biotech Bankruptcies/Liquidations/Dissolutions
[Added DMTK.]
*Emerged from bankruptcy as FCSC.
iHub
Company Date Reference
ACOR 4/24 #msg-174156166
ADLS 5/11 #msg-62813901
AFFY 6/14 #msg-103663749
AGIX 1/09 #msg-35019458
AKAO 4/19 #msg-148227772
ALNA 9/22 #msg-169875553
ALPIX.PA 11/23 #msg-173275218
ALTU 11/09 #msg-43509933
AMB.TO 8/09 #msg-40145970
AMPE 4/24 #msg-174111257
ANSV 1/10 #msg-45161615
ARAV 1/24 #msg-173646720
ARDM 2/19 #msg-146903332
ARLZ 8/18 #msg-142824112
ARNI 12/17 #msg-137120846
ARTE 12/08 #msg-33895436
ASP.TO 1/23 #msg-171046860
ATHX 1/24 #msg-173589749
ATNX 5/23 #msg-171913749
AXLA 12/23 #msg-173374718
BAXS 11/14 #msg-108147336
BCART.BR 9/23 #msg-172903024
BIND 5/16 #msg-122328088
BIOA 5/18 #msg-140549553
Biolex 7/12 #msg-77324773
BPUR 7/09 #msg-39629524
BTTX 3/24 #msg-174037486
BVTI‡ 3/13 #msg-85440257
CALA 1/23 #msg-170898055
CBIO 6/22 #msg-169273606
CDAK 3/23 #msg-171544942
CJB.TO 7/10 #msg-52557510
CHKT 12/08 #msg-33949508
CLSC 8/09 #msg-40685152
CLVS 12/22 #msg-170599077
CRXT 9/22 #msg-170229149
CWBR 11/23 #msg-173138450
DCGN 11/09 #msg-43629379
DDXS 6/16 #msg-123229557
DMK 2/24 #msg-173773814
DMTK 6/24 #msg-174619409
DNDN 11/14 #msg-108004147
DXTR 12/17 #msg-136829445
Egenix 1/15 #msg-109921347
EIGR 4/24 #msg-174151841
ENDP 8/22 #msg-169707980
Epix† 7/09 #msg-39900524
EPRS 7/16 #msg-123687350
EYES 6/20 #msg-156388471
FRTX 9/23 #msg-172854853
GMDA 3/24 #msg-174125313
GNCA 5/22 #msg-168957883
GNTA 8/12 #msg-78123007
GTOP 9/08 #msg-32249160
HEMA 4/12 #msg-74167597
HGEN 7/23 #msg-172432338
HSTO 9/23 #msg-172847239
IGXT 5/24 #msg-174439828
ILIU 7/17 #msg-133264435
IMMG 8/17 #msg-134305213
IMNP 2/19 #msg-146936897
IMV 5/23 #msg-171814610
INFI 10/23 #msg-172941539
Inspiration 10/12 #msg-81024196
INSY 6/19 #msg-149302493
Introgen†† 12/08 #msg-33947783
Isolagen* 6/09 #msg-38746197
KBIO 12/15 #msg-119489701
KLDO 4/22 #msg-168491485
KV.A 8/12 #msg-78203130
LBPS 6/22 #msg-169255625
LHDX 2/22 #msg-171275021
LIAN 2/24 #msg-173835088
LMDX 12/23 #msg-173530663
MACK 2/24 #msg-173845049
MBRK 4/10 #msg-49658072
MBVX 3/19 #msg-151985211
MIIS 11/08 #msg-33720220
MIPI 12/10 #msg-57646943
MLNT 12/19 #msg-153074747
MNK 10/20 #msg-158843178
MRV.TO 3/23 PR link
NBSE 3/24 #msg-174119874
NEXI 11/23 #msg-173152495
NMTI 4/11 #msg-62251315
NMTR 7/23 SEC link
NOVN 7/23 #msg-172361873
NRGX 3/12 #msg-73415156
NRX 5/16 #msg-122331475
NSTG 2/24 #msg-173773766
NVDL 2/17 #msg-128923029
NVIV 2/24 #msg-173755991
NVLN 1/20 #msg-153111867
NVTA 2/24 #msg-173844970
OBSN.SW 2/24 #msg-173937364
ODT 3/21 #msg-162706983
ONCR 6/23 #msg-172037432
ONCS 6/23 #msg-172145325
OREX 3/18 #msg-139213097
ORPH 3/22 #msg-168169591
OSCI 7/09 #msg-39511719
OTIC 12/22 #msg-170737355
PEAR 4/23 #msg-171639648
PHAS 10/22 #msg-170272758
PLXP 4/23 #msg-171677346
PROMO.ST 10/23 #msg-173007859
PTX 2/19 #msg-146937356
PYMX 4/13 #msg-86313192
PZRX 12/17 #msg-136794351
QTNT 12/22 #msg-170676963
RCPI 8/16 #msg-127560117
REX 11/08 #msg-32189097
ROKA 8/17 #msg-133945967
ROSG 6/18 #msg-141797330
RUBY 2/22 #msg-171270235
RVALL 1/20 #msg-153358221
RVLP 10/23 #msg-173007859
RXPC 7/14 #msg-104103329
SCLX 2/23 #msg-171193757
SGYP 12/18 #msg-145394802
SIEN 2/24 #msg-173834941
SIGA 9/14 #msg-106313111
SIOX 12/22 #msg-170699458
SNNA 9/19 #msg-151196707
SPHS 5/20 #msg-155712447
SRGA 6/23 #msg-172201878
SRNE 2/23 #msg-171193757
SVNT 10/13 #msg-92997648
TDLP 6/11 #msg-64744114
TLCV 12/09 #msg-44751578
TMBR 11/23 #msg-173254229
TOMDF 12/23 #msg-173490278
TPPH 2/08 #msg-26765260
VION 12/09 #msg-44654555
VLRX 2/20 #msg-153741993
VRA 10/07 #msg-18053275
VRAY 7/23 #msg-172361873
VVUS 7/20 #msg-156752080
ZSAN 6/22 #msg-169035970
DMTK files for bankruptcy:
https://www.businesswire.com/news/home/20240618662927/en
See #msg-152767851 for background info.
ZNTL—(-38%)—FDA partial clinical hold on_three Azenosertib trials_due_to_patient deaths:
https://www.globenewswire.com/news-release/2024/06/18/2900260/0/en/Zentalis-Pharmaceuticals-Provides-Update-on-Azenosertib-Clinical-Development-Program.html
See #msg-174616324—the post immediately following yours.
There are several approved oral vaccines—see Table 2 in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10383709/ . However, I don’t know of any companies other than VXRT who are focused on developing new oral vaccines. The question asked by WL at the bottom of #msg-174618770 would seem to be highly relevant for viruses such as SARS-CoV-2 and flu that mutate rapidly.
VXRT - all I know is they've been working on a 'pill form' vaccine since before covid. During covid, VXRT was a volatile stock as were most all vaccine stocks. After covid waned, the pp drifted downward.
IMO, the 'pill-form' idea is a great attribute, the sizeable funding an even greater attribute, and the commitment from HHS should make the Nightly News, possibly multiple times as these trials advance?
why the pps tanked on what should be extraordinary news in a small obscure biotech? I've been adding shares down to mid-.50's.
Question for this board: Anyone know of any other biotech-companies working on a pill-form-vaccine?
VXRT .59 - the secondary at $.80 and very poor promotion of the HHS Secretary's commitment are my best guesses why the pps tanked on what should be extraordinary news in a small obscure biotech? I've been adding shares down to mid-.50's.
“We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”
The project awards were made through BARDA’s Rapid Response Partnership Vehicle (RRPV ) to support the following companies in planning for and preparing the vaccine candidates for Phase 2b clinical trials:
Up to $453 million to Vaxart of San Francisco, California, developing an oral pill vaccine candidate, adenovirus serotype 5 (Ad-5). BARDA will provide an initial $65.7 million for early trial milestones, with remaining funds provided as the effort successfully advances toward trial execution. Vaxart will execute its own Phase 2b clinical trials.
https://www.hhs.gov/about/news/2024/06/13/barda-awards-500-million-project-nextgen-funding-vaccine-clinical-trials.html
Question for this board: Anyone know of any other biotech-companies working on a pill-form-vaccine?
Do a web search on: FDA response letter to a SPA request prnewswire
Mainly provides comments that companies will submit an SPA or that they’ve received a response letter. Never seen a company that released the entire thing. Normally it’s just a quick summary, often spun to reassure investors.
Then again, prnewswire is just a PR website, annd PRs are normally short and to the point with boilerplate disclaimers.
————
You could try a freedom of information act request to see it if you really wanted, but it is possible [I do not know] that it might be barred or redacted by exemption #4.
https://www.foia.gov/faq.html
Not all records are required to be released under the FOIA. Congress established nine exemptions from disclosure for certain categories of information to protect against certain harms, such as an invasion of personal privacy, or harm to law enforcement investigations. The FOIA authorizes agencies to withhold information when they reasonably foresee that disclosure would harm an interest protected by one of these nine exemptions.
The nine exemptions are described below.
Exemption 4: Trade secrets or commercial or financial information that is confidential or privileged.
VKTX- Viking's Kader Yagiz Ph. D. (Scientific Lead) is publishing a paper entitled "2064-LB: Novel Amylin and Calcitonin Receptor Coagonists Reduce Food Intake and Body Weight in Rodents":
We developed a series of novel long-acting amylin agonists to assess the potency on both calcitonin (CTR) and amylin 3 (AMY3) receptor activation on body weight and other metabolic parameters.... Diet-induced obese (DIO) mice were treated with subcutaneous injections of vehicle or one of a series of amylin agonists for 24 days. Cagrilintide was used as positive control. Cohorts were assessed for changes in BW, food intake and other markers. A series of amylin agonists reduced food intake in rats in the range of 56-93%, compared to vehicle,
$VKTX Amazing - great work from Viking https://t.co/UDASKWRJOk
— Jim Hansen (@fluffer9) June 18, 2024
VKTX Viking Amylin: Anyone have more insight on how these results compare to other pre-clinical studies and/or how effective it would be on humans?
https://diabetesjournals.org/diabetes/article/73/Supplement_1/2064-LB/155758/2064-LB-Novel-Amylin-and-Calcitonin-Receptor
You're not allowed to exit the thread now, LOL.
VXRT—…an underwritten offering of 50,000,000 shares of its common stock at an offering price of $0.80 per share, which is a premium to the last closing price of $0.75 per share.
VXRT did a capital raise the same day as BARDA:
June 13, 2024
PDF Version
Vaxart Announces $40 Million Underwritten Offering of Common Stock
SOUTH SAN FRANCISCO, Calif. , June 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (“Vaxart”) (Nasdaq: VXRT) today announced an underwritten offering of 50,000,000 shares of its common stock at an offering price of $0.80 per share, which is a premium to the last closing price of $0.75 per share.
June 13, 2024
PDF Version
Vaxart Receives BARDA-Funded Project NextGen Award Valued Up to $453 Million to Conduct a Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate
— 10,000-subject Phase 2b study will evaluate Vaxart’s next generation oral pill COVID-19 vaccine against an approved mRNA vaccine comparator — — Vaxart anticipates initiating enrollment as early as summer 2024 — SOUTH SAN FRANCISCO, Calif. , June 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc.
FDA approves MRK’s Capvaxive—(f/k/a V116)—pneumococcal vaccine for adults:
https://www.businesswire.com/news/home/20240614126575/en
With this approval, MRK should finally get a decent share of the market for adult pneumococcal vaccines, where PFE’s Prevnar franchise has long been dominant.
Please see #msg-173458310 and #msg-172452293 for related info.
VXRT issues PR with no new news (AFAIK) in apparent attempt to counter the 30% share-price decline since BARDA announcement on 6/13/24:
https://www.globenewswire.com/news-release/2024/06/17/2900005/25416/en/Vaxart-Provides-Business-Update.html
I don’t know why the BARDA contract induced a sharp selloff.
Can such technology be sufficiently accurate to compete with ABT and DXCM? I have my doubts...
Upon calibration and time lag removal, the data indicate a Mean Absolute Relative Difference (MARD) of 12.9% and Precision Absolute Relative Difference of 13.1%. In view of these results, we discuss the potential value and limitations of MHD in needle-free glucose monitoring.
ASMB raises additional $12.6M from GILD and Armistice Capital in warrant-laden transactions:
https://www.globenewswire.com/news-release/2024/06/17/2899596/16259/en/Assembly-Biosciences-Announces-12-6-Million-in-Equity-Financings.html
Assembly Bio sold 634,500 shares of common stock and warrants to purchase up to 634,500 shares to Armistice Capital, and sold 179,500 shares of common stock and warrants to purchase up to 179,500 shares to Gilead, in each case, at a combined price of $15.46 per share of common stock and accompanying warrant. The warrants have an exercise price of $17.00 per share of common stock, will be immediately exercisable and will expire on June 18, 2029.
Assembly Bio currently expects to use the net proceeds from the equity financings for general corporate purposes [i.e. for clinical trials in HBV and HDV].
This private company has a needle-free CGM:
https://www.globenewswire.com/news-release/2024/06/17/2899338/0/en/Talisman-needle-free-CGM-demonstrates-strong-correlation-to-blood-glucose-in-clinical-studies-and-moves-towards-large-volume-manufacturing.html
Talisman is a wearable CGM that uses MHD [magnetohydrodynamic] technology to extract interstitial fluid (ISF) from the skin without the use of needles. By integrating ultra-sensitive and low-cost biosensors, Talisman enables continuous, painless, and accurate monitoring of glucose levels.
OVID—(-70%)—Takeda’s Soticlestat phase-3 trial narrowly misses primary endpoint—(p=0.06):
https://www.globenewswire.com/news-release/2024/06/17/2899490/0/en/Ovid-Therapeutics-Reports-on-Takeda-s-Announcement-of-Phase-3-Topline-Study-Results-for-Soticlestat.html
OVID sold Soticlestat’s worldwide commercial rights back to Takeda in 2021 in return for sizable milestone payments and royalties (https://www.takeda.com/newsroom/newsreleases/2021/takeda-secures-global-rights-from-ovid-therapeutics-to-develop-and-commercialize-soticlestat-for-the-treatment-of-children-and-adults-with-dravet-syndrome-and-lennox-gastaut-syndrome/ ), which are now unlikely to be received. As a result, OVID is now trading at roughly net-cash value.
FWIW my top three concerns regarding OCUL as a long have not been brought up.
I don't know of any. Which company do you have in mind?
Dew:
These people scare me!
Sorry, but my faith in their predictions are worse than tabloid hype.
Does anyone know of any company that has publicly shared the actual FDA response letter to a SPA request?
How could "every single patient" be any clearer?
Suspect that they are assuming ‘rescue’ is anyone approved by their two rescue adjudicator gods
Just saw iwfal's reply to the same post, and I concur that a sham non-injection may not be adequately masked to the patient.
In summary, this study has demonstrated that a sham intravitreal injection can successfully mask study participants to treatment group assignment when a detailed procedure is followed which attempts to carefully mimic a true injection procedure. Masking may be less successful when one eye receives real injections and the other eye receives sham injections or an individual eye receives both real and sham injections.
I suppose so, but redosing a 9-month implant after 6 months might send a confusing message.
Isn't he also implicitly saying that a bird-flu bioweapon is rather likely?
...I do wonder what the effect of having extra drug in the eye for 2-3 months is...
...if successful, the OCUL re-dose trial should be fantastic commercially.
[Redfield's] just saying the end result (a pandemic) is almost inevitable, but the timeframe to get there is dependent upon whether human created or arising naturally. (Human creation would be quicker).
The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Previously, sham injections were done on an anesthetized eye by pressing an injector with no needle against the eye. For masking purposes [such] an injection…would be an option.
The following answer at around 1:29 responding to a question the Bank of America analyst at 1:28 seems to be indicating that patients who are rescued count as a failure.
Previously, sham injections were done on an anesthetized eye by pressing an injector with no needle against the eye.
I find this article perplexing insofar as Redfield says a bird-flu pandemic is all but inevitable while also opining that the risk from a lab-grown bird-flu virus is greater than the risk from eventual animal to human transmission. I cannot reconcile the two statements
From the guidelines:
The use of the word should in Agency guidances means that something is suggested or recommended, but
not required
Control can be the vehicle of the investigational drug or another drug
Re: OCUL and EYPT -- who says sham injections are not allowed/favored by the FDA?
I previously posted that the draft FDA guidance doesn't say this explicitly but in slide 30 of the OCUL slide deck, they state:
Sham injections are not recommended due to inadequate masking2
...
2. Special Protocol Assessment for OTX-TKI pivotal trials.
Re: OCUL
How will "rescued" patients be treated in the statistical analysis?
That 20% mark is important. We absolutely are very confident about it the way that it was derived as through some internal modeling, as well as with some publicly available data. We haven’t guided you to those internal modeling, we may in the near future, but here’s what I would tell you. There are two are things are really important to understand regarding that. One is retreatment, realize that every single patient who is retreated whether on protocol or off protocol must be counted in the primary analysis and that’s very much in our favor which means they’ll be many more such patients in the Eyelea group as opposed, we believe, as opposed to the Axpaxli group so they are all counted. They’re not censored, but they’re all counted so that’s a really important statement, second thing I will tell you in terms of powering in terms of powering we are powered we believe that they’ll be a Delta of 50% based on which just said between the Axpaxli group or we expect more than 70% of patients to maintain vision as opposed to the Eyelea group where it would be approximately 20% for the reason that I mentioned so a 50% delta. We need a 15% delta, 15, to be statistically significant so we have very very large safety that there, even if there should be something on anticipated in the control group which we don’t think there will be based on our modeling.
Former CDC director predicts bird flu pandemic:
https://thehill.com/policy/healthcare/4723753-former-cdc-director-predicts-bird-flu-pandemic/
Former Centers for Disease Control and Prevention (CDC) Director Robert Redfield said he predicts a bird flu pandemic will happen — it’s just a matter of when that will be.
… He also noted that bird flu has a “significant mortality” when it enters humans compared to COVID-19. Redfield predicts the mortality is “probably somewhere between 25 and 50 percent…” [vs. an estimated 0.6% for COVID].
…There is no evidence yet that the virus is spreading between humans. …Scientists have found that five amino acids must change in the key receptor in order for bird flu to gain a propensity to bind to a human receptor “and then be able to go human to human” like COVID-19 did, Redfield said.
…More than 40 cattle herds nationwide have confirmed cases of the virus. …Since cattle live close to pigs and the virus is able to evolve from pigs to humans, there is cause for concern.
… Still, [Redfield] argued, there is greater risk for the disease to be lab-grown. “I know exactly what amino acids I have to change because in 2012, against my recommendation, the scientists that did these experiments actually published them,” he said. “So, the recipe for how to make bird flu highly [infectious] for humans is already out there.”
...rescued patients will NOT be censored.
OCUL
One question that did not come up and is something that makes me wonder is about the re-dose schedule for Sol-R.
Comparing EYPT and OCUL trials as proposed:
EYPT @ 6 months - drug gone, some % of patients need rescue prior to re-dose, carrier vehicle still present to some degree.
OCUL @ 6 months - drug and carrier present, prior rescue unlikely, carrier vehicle still present to some degree.
I haven't found it in slide decks (thus far) but going from memory OCUL is designed to release a final amount of drug at the end of life of the carrier around 8-9 months. By comparison EYPT drug is clearly gone by 6 months and I don't recall the expected eluting pattern, however they had >10% 'supplement' (rescue) at 5 months and > 20% at 6 months. https://investors.eyepointpharma.com/static-files/2f2e6f27-26f6-400f-9e52-a3fec5885ea7 with roughly 2/3 rescue free at month 8.
Both have some kind of "stacking" issue with the carrier at 6 months that probably isn't relevant for the majority of patients.
I do wonder what the effect of having extra drug in the eye for 2-3 months is versus not having enough drug to sustain stable vision for what is probably a high percentage of patients on the other hand. (Current SOC patients also have the problem of the drug being gone, by definition. That is one compelling point of sustained release.) Also, EyleaHD should make my concerns irrelevant?
In practice with approved drugs the dosing schedule would be adjusted to the patient need as insurance allows, which is mostly guided by label.
Given the OCUL team has a lot more experience and success designing registrational trials for AMD than I have criticizing such trials, I wouldn't make too much of this commentary and, if successful, the OCUL re-dose trial should be fantastic commercially.
They said at least twice that rescued patients will NOT be censored.
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