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I don't want to get into conjecture and timelines.
I literally have paper timelines for this company-progression spread all over the far end of my dining room table, and every single one of them I've outlined has been blown to pieces.
We have no idea with Leo, when things will get filed and what the response will be. I'm feeling like the FDA is moving faster than usual through CTAP to review IND submissions currently.
I'm also feeling like the results from the RBL are pretty comprehensive and compelling. Possibly more compelling (significantly) than many other prospective molecules coming before the FDA?
W/respect to foreign review processes... I don't even want to hazard a guess. All bets related to timelines are off for RU I think.
In places where speed can be 'negotiated', the sky is the limit.
Given pandemic-urgency, I'd like to think that time-is-of-the-essence.
Were it me, I'd consider some sort of license percentage-contribution for the country stockpile as a percentage of Net, perhaps... in lieu of cash-upfront?
always welcome.
Hope it helped.
...of course, you're welcome.
It's an interesting read for sure...
This is what the language from the Q actually says:
If I were to guess (and I hate guessing about anything related to this stuff), I'd like to think that built into the trial-design, the Bio-Markers likely placed will be fairly close-in, so after a reasonable number of days elapsed from dose administration (let's say 5 days, for example) samples pulled would be subject to viral-titer analysis, whereupon efficacy could be determined to some extent. (B is either reducing the viral load or it isn't, in humans...)
Leo's CRO would likely have a certified lab contracted to do the sample analysis for 3rd party unbiased verification.
I'd think that upon sample-data being compiled and updated for 'interested parties' based on bioMarkers being placed, that some prospective 'partnership' interests might be resolved... (this wouldn't necessarily mean that results would be made immediately public, however.)
FWIW, there was some BP entity that was granted an IND earlier this year, something like 36hrs after package submission (I'm drawing a blank on the company currently). So it CAN go quickly... if the package is super-comprehensive and complete and assuming the pre-IND process was as detailed as possible (is my understanding).
Pete... you seem to be confusing the PRE-IND component with the IND component, based upon your post.
Our IND wasn't submitted previously, and hasn't yet been submitted. Only the pre-IND package, to which a 'written response received' by the FDA was announced.
Just because people on this board make assumptions that things like the 'IND was submitted', doesn't make them so.
I'd been saying for weeks (literally) that the IND hadn't been submitted yet, and nobody wanted to listen.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/pre-ind-consultation-program
This might not be the worst place to begin your reading:
http://www.biorasi.com/assests/white-papers/Biorasi%20-%20Navigating%20through%20the%20Clinical%20Trial%20Authorization%20Process%20in%20Russia-v0-1.pdf
...
...could be a super-relevant question for us very shortly ;)
Who is pushing things back here?
The guy running the company, PR'ing about things to come that never happen, or some anon on a message board?
My feeling: Leo is the log-jam here. I feel like he's holding out for a price that's beyond what's previously been on the table.
B-C19 hopefully will change that, and I believe us to be on track to have a statistically significant clinical trial event lined up to precipitate something along the lines of a legitimate partnership (as opposed to a $400k one).
Having an overseas trial would bypass the wait for the IND approval (or default), and would expedite the timeline. Having biomarkers in place prior to an interim at 30 days (if it's a 2mo trial) will hopefully provide solid enough feedback to trigger a major partnership to move the indication significantly beyond what Leo would be able to do alone.
IMO, this is dead if Leo tries to go it alone.
(Reminder: The answering machine nonsense with the phone, the building lease, the uplist... etc, etc. )
IND hasn’t even been filed-for yet.
Can’t start trials domestically until we have some sort of response, post-filing.
Abroad, trials can start, but what’s the status of those?
Consider where regulation is lax, in the Pharma-sector.
Further East than E. EU, perhaps...
... that post was updated. We can't BOTH be crazy... ;)
(yes, I saw it...)
Thanks. Your update to include 'B-OM' wasn't present earlier... which is what my query was based upon.
Where are you getting this info?
Oh, you just changed your post I think.
B-OM reference wasn't there when I posted this.
Thank you for the clarification.
(My reply was with respect to C19)
Short answer to your question concerning 'Do you think the company would file an IND w/o publicizing it?' A: No
To my knowledge, they haven't (heard/filed), but it's been a week or so, since I've been in contact, so things may have changed.
The 30 day window post-IND application to 'proceed' if no response has been given, hasn't been triggered yet... so this 'countdown' is just burning up the proverbial clock, with respect to getting things moving in any direction. IF Leo were actually involved with CTAP, you'd like to think that they'd be on board with fast tracking Brilacidin, given the unverified 'amazing results' to-date for the drug.
IND Process:
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview
This was additionally confusing to some extent; posted by the FDA:
'...For the purposes of our response to the COVID-19 public health emergency, we are consolidating the typical pre-IND meeting request and package development process into a single step.'
https://www.fda.gov/media/137927/download
ummm... ok. SO 'guidance' and then you run your trial based on recommendations?
Lol, remove what exactly?
The only funding mechanism available to Leo?
Sorrento is moving on their P2 in Brasil.
https://investors.sorrentotherapeutics.com/news-releases/news-release-details/brazilian-health-regulatory-agency-anvisa-authorizes-sorrento
Wondering why we still have nothing meaningful from Leo about much of anything...1/2 way into October, and crickets...
P2 abroad in an Eastern EU country / RU, would be quick. Rising cases. Less expensive. Less regulation.
You're joking, right?
https://finance.yahoo.com/quote/IPIX/key-statistics?p=IPIX
this is what a 'pre-revenue' nightmare looks like, just FYI.
I feel like we’re seeing at least one of these appear almost weekly now...
Concern about the time of development for Brilacidin is REAL.
https://flip.it/vaghCv
It wouldn't appear that IPIX is on Gilead's radar concerning Remdesivir and 'combo-therapy'...
https://www.fiercebiotech.com/biotech/can-a-plasma-based-treatment-boost-remdesivir-nih-starts-phase-3-trial-to-find-out?mkt_tok=eyJpIjoiTURNNE1UTmtZalF3TWpNeiIsInQiOiI3TVh1eFY5U0NcLytVcmNYQlNQb09hTWdEMmtXb2VCMldTV0llV1NLYnlOWGZKVlVTVWJxWktuUXI4UjlXRDZqbk1XRm42bk1JZTYxd1lcL1lWcnJKaGdvR3JmdDhvXC8wdFhcLzYyekQ4dERGWXQzQU42MkhVY20yd2prcWtvSFc3XC9TbGZ1UEFtMWJZTzRpdVhHRDlPMEJwQT09In0%3D&mrkid=74197490
Can someone answer this with some facts plz?-
Why is it that the RBL's aren't named to-date?
NDA or otherwise, GMU, if in fact is involved, has been PR'ing or been PR'd about by others related to COVID.
What's Leo hiding and why?
- Innova https://www.newsbreak.com/news/2040968559040/inova-health-gmu-partner-with-state-on-covid-19-antibody-study-in-children
- Chimeron https://www.businesswire.com/news/home/20200528005481/en/Chimeron-Bio-and-George-Mason-University%E2%80%99s-National-Center-for-Biodefense-and-Infectious-Diseases-Partner-to-Develop-a-Coronavirus-COVID-19-Vaccine-using-ChaESARTM-Technology
- Emergex https://emergexvaccines.com/emergex-signs-agreement-with-george-mason-university-for-highly-pathogenic-rna-virus-studies/
Also... people keep talking about '3rd party validation', yet we've literally had none related to SARS CoV-2. Not a peep from the NIH, or the 'RBL's involved'. Who are they even?
The only info we've seen to-date has come from Leo. Why is that?
Updated trial-info related to Remdesivir (and others), to which we've been 'compared'.
- https://clinicaltrials.gov/ct2/show/NCT04315948
I've also wondered why all the hiding of concrete data in the PR's?
It's not like the 'labs' are providing general figures. They would be giving specifics.
In case you're wondering what a proper and informative PR looks like within the space, look no further than Sorrento Therapeutics:
https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-releases-preclinical-data-sti-1499-covi-guardtm-and-sti
(regardless of whether or not you approve/agree with what they're up to, at least they're providing useful information with specifics).
Yes, should've been submitted a month ago or more, but at least now it's in.
https://www.fda.gov/media/137927/download
I'd be surprised if we don't see an EUA (Emergency Use Authorization) applied-for following the interim analysis, personally.
- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/summary-process-eua-issuance
-https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-declaration
-**https://www.federalregister.gov/documents/2020/09/11/2020-20041/authorizations-and-revocation-of-emergency-use-of-drugs-during-the-covid-19-pandemic-availability **
interesting info on HCQ and the rejection notice, along with examples of approvals and material referenced in the last link.
I feel like given positive interim results for B as a single-dose IV administered drug, going to BARDA + FDA for an EUA approval would make sense. BARDA for funds to ramp production immediately and on a massive scale, and to concurrently run treatment + a P3 possibly for C19. I'd also be looking for a massive partnership at that time. In lieu of a partnership, CTAP could prove useful for distribution management, but only domestically. Partnership would be useful worldwide.
A hostile takeover is not possible currently, given current structure and voting-allocation (unless I’m reading the last Q incorrectly.). LR will likely verify (or offer insight).
...and to your question: F*ck YES I’d be 100% for a hostile takeover... if it were possible... by a BP (Pfizer, J&J, Sanofi et.al). SOLID management + funding + vertical integration + functional strategy and a lengthy history of execution... compared to what we’ve got now?!?! How could you not want that?
Drugs actually seeing the light of day, compared to burning up patents needlessly, and watching good science die at the hands of bad management...
I think some people forget why they’re ‘invested’ in this company. Seeing the science APPROVED should be the only reason your cash is invested here. We need PRODUCTS to be approved and monetized. The longer it takes, the less they’re worth. Time Value of Money. Nothing else should matter to Leo.
BINGO
NOW you're smelling what I'm steppin in.
Not sure why everyone's got 'enable-Leo-mode' engaged and has their heads in their collective asses about all this stuff?
Leo's sauna-buddies on the board providing exactly zero oversight.
No shareholder meetings.
Pumping PR's and then selling into any movement to 'capitalize' the company and pay Leo's salary. Seldom-run trials to keep the interest alive...
I could go on...
Grrrrrrrr
This is what I was alluding to yesterday, and I believe the answer to be 'yes'.
I don't know the concentrations from the ABSSI P1 dosing and we don't have concrete info from the C19 IC50/90, but I believe the data to be sufficient with additional input from the GMU RBL, to not require further animal-testing. My understanding is they're (RBL) working with IPIX to sort dosing data for the IND.
Hoping and praying that the existing P1 data from the B-ABSSI trial will suffice.
I also hope the dosing and tox info provided by the GMU RBL will suffice to allow progression. The C19 IC50 dose concentration if compared to the ABSSI dose-ranging info along with concentration could shed light as well?
Leo's been introduced to the Warp Speed RBL lab and the guy who developed the mouse-models for SARS CoV-2 testing, and has access to expedited animal-model testing should it be required.
Fingers are crossed and Mary is being hailed...
Politics can play a role related to lobby-dollars getting priority-review with the FDA related to repurposed drugs, yes. And they have.
Filing an IND // pre-IND has exactly zero to do with politics. You gather your materials and findings and submit your brief.
Please familiarize yourself with the brief-requirements here: https://www.fda.gov/media/137927/download
Meeting request info here: https://www.accessdata.fda.gov/cder/sb-navigate/topic3/topic3/da_01_03_0300.htm
CTAP info here: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap#:~:text=Vaccines%20(ACTIV)%20Partnership-,What%20is%20CTAP%3F,they%20are%20helpful%20or%20harmful
This is not 'political' just like taking your MCAT or GRE is not 'political'.
I believe us to currently have RBL 'priority' with Aarthi's lab, as we've been one of the most 'promising candidates to date'. But yes, the labs have been bogged-down with every harry-dick-and-sally BioTech sending in their 'candidates' for testing. We've had to wait our turn and the findings have demonstrated that we have a superior molecule on a number of levels related to C19.
I'm not a PhD Virologist so I'm not here to argue with my friend. I listen to what the experts have to say and trust them. If he says he's seen companies submit IND's based on far-less than what IPIX had PR'd to-date as of mid-Aug,(with subsequent approvals) then I trust what his lab has seen.
I understand all of your concerns.
My concern is: this is a pandemic, and quite literally ALL of the best and brightest minds are working to address the issue at hand. Finding a vaccine and therapeutics... hell, anything that works to save lives is being explored globally.
If this isn't a time to 'rush', then when is?
Doing it diligently and accurately is required of course, but if a scientist-friend who works at a government lab says: Leo has enough info to file his IND and should have done so based on everything he's seen go through his lab... then my question is: why hasn't Leo filed the pre/IND? WTF is he waiting for?
I get that he doesn't have product-in-hand yet. But it's not an IND requirement.
If he needs cash for the trial, raising it into strength reflected in an elevated SP makes more sense than trying to do it where it stands. No?
SO again... WTF is going on over there at LeoPharma?
(literally the only thing I can think of is: they're deep in negotiations with a BP for the indication and dotting the i's and crossing the t's and both parties are under NDA)
Yes, DeGrado 'advising' is great.
Sure, news related to Kevetrin is great. But irrelevant given the COH situation currently.
Yes, great to hear the RBL's like the molecule. But 'liking' the molecule isn't saving lives now is it?
Action, not talk. That's what time it is...
I'll never understand the willful-ignorance of Leo's misleading PR's and constant fluff/BS.
Timelines are seldom referred to (milestone dates/windows), and when they are, they've literally never been met (since I've been invested here).
You don't have to even look beyond the last PR with anything of import in it to 24 Aug, when we got mention of several things that require greater clarification (I'd consider these 'hot air').
1.
I’m currently sitting at around -80% with my long-term-held wad of shares.
If this isn’t ‘crushing shareholders’... than I’d love to hear your specific definition?
How many drugs has Leo delivered to market since company founding in 2005?
What’s IPIX’ revenue stream look like?
How many partners involved and to what extent?
We’re all seeing the same PR’s... are we not?
What’s your definition of ‘hot air’ ?
I'm not sure about the 'hardball with BP' ever being a reality, as much as just getting the final results and the PrePrint completed and out there?
Results from P2, if compelling, should give us an opportunity for a possible license/partnership, which if Leo's got any hope of the rest of the pipeline going anywhere, would make sense to capitalize upon.
IBD awaits, along with other indications, none of which go anywhere on $6M, unless C19 is leveraged, IMO.
I'm hoping for updates this week related to IND submission brief and a meeting. It'd also help to have some trial-site info, CRO info, manufacturing-complete announcement etc.
It's always SO painful with this company.
I'm ready to have some 3rd party-verified progress we can lean on.
I sort of feel like manufacturing would be a current expense?
(could be for both IV as well as IBD)
IBD and/or B-OM related developmental expenses?
Kevetrin tox-study completion and reform-expenses?
CRO for B-IBD expenses?
Along with paying a CRO or possibly 2 for upcoming SARS CoV-2 trials?
Contractors for regulatory assistance for SARS CoV-2 etc?
Additionally, who knows?
$1.4M goes pretty quickly with a handful of indications running...
I'm 10000000% with you.
The only thing holding us back is the lack of funds and personnel.
If the company was funded properly (and fully built-out), we could be running multiple trials simultaneously, actively managing reformulations, doing in-house R&D to explore further relevant indications, etc.