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Can anyone familiar with this type of subsidiary arrangement please expand/elaborate on the benefits of having a subsidiary in Europe? Is anyone aware of other small pharma companies doing/having done something similar?
Many thanks in advance.
Is our share count already so high that $2-3 billion would only fetch $1.70 per share?
EDIT - never mind, assume you are calculating off the $500 million. Makes sense from what I last recall.
Haven't been paying attention too closely - is the drop yesterday expected to be from raising capital through LPC?
Unless the government shutdown has affected our work with the FDA, I assume we'll hear more about the P3 OM trial design in short order as 30 calendar days from the end of P2 meeting will hit tomorrow or Thursday.
Can't recall - the FDA has 30 business days or 30 days total to release/provide the meeting minutes to IPIX?
TIA!
I don't see any other way to uplist near-ish term given the current share price and I don't think they'll want to languish on the OTC for the next couple years. Exposure they'd gain with institutions and analysts, once listed, might be worth it.
IMO, there are three possible scenarios:
1) Deal followed by RS followed by PIPE
2) RS followed immediately by Deal to prevent further SP deterioration
3) No deal and a significant RS (~75:1) followed by a PIPE
It may be naive, but I don't see them folding at this stage of asset development
...and then presumably also be able to pay the CRO in full for the Prurisol results
Let's follow up on this subject in another week. Wouldn't failure to garner BTD constitute a material event subject to public disclosure? At the very least, we, and any potential partners will have all the cards laid out by the FDA after their End of Phase 2 meeting in mid-late December. At that point, I'd imagine all "DD" would be satisfied and any interested parties would make their final offers. I'll predict January for a partnership if BTD is not granted in the next 7 days, otherwise I think we go it alone after a RS and new funding arrangement.
Seems like a lot to ask given our current SP levels and the likelihood that such a move would necessitate an uplist and institutions buying. I hope you are right, but at this point I would be surprised if we were to rise much over $1. With the addition of solid Prurisol trial results and another partnership/asset sale I think we could get there, but otherwise we may still need a RS in order to uplist IMO.
For fun: Assuming a partnership deal with ~$20 million upfront payment with $250 million in milestone payments for B-OM/B-IBD, at what point would institutions start buying? After the share price exceeds a certain amount? After an uplist?
Perhaps. Last year it was released on 11/8
10-Q next week followed by the IBD Crohn's & Colitis Conference the week after on the 13th. Hopefully something else as well before Thanksgiving
Thanks for keeping the facts in check, I stand corrected. Although, given the advantages you cited, it doesn't change my personal opinion that BTD would/could alleviate BP worries over a Phase 3 trial design and not necessitate that the EOP 2 be held before a partnership agreement would be signed.
The presumption on my end was that if given BTD and priority review, the guidance (given in an EOP 2 meeting) for a Phase 3 trial would not include overly burdensome requests so our potential partner would not need to wait on the results of that meeting before deciding whether to execute the partnership agreement.
"Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs."
In a similar vein, wouldn't the FDA granting BTD almost eliminate any potential concerns from BP for a B-OM Phase 3 trial design??? Can't imagine they'd need to wait until after the End of Phase 2 meeting to execute the agreement if IPIX is granted BTD. All just my opinion, and not that I would expect them to sign immediately after granting of BTD but within several weeks would seem likely.
The company will realize $2.2 million over the first 30 days of the new financing agreement (starting October 9th) so they are not cash flush at the moment. I'm sure they don't have enough cash at this point to pay off the P CRO and why would they blow it on an unknown when they need money to pay salaries until a B deal is finalized?
" it has secured new financing for up to $10 million from one multi-family office focused on healthcare and life sciences, including an initial net placement of approximately $2.2 million over the first 30 days."
Ha - to flip that around, at this point my IPIX dollars are pennies so I'd be thrilled with a multi-billion dollar buyout. But, more is always welcome!
I'd happily take 2.1 B in a buyout ;)
Unless they already know the results, I'd be shocked if IPIX used these proceeds for Prurisol. It'd be too risky when they now have cash to keep them going for the next several months and could ink a deal during that time for B.
Yes very interesting indeed, good find.
Also, this quote from the PR:
“This new financing.... gives us flexibility in working to meet our near-term goals, which includes advancing Brilacidin into a pivotal study,”
We know they don't plan on getting B into a pivotal study alone. Sounds like they're buying time until the partnership is finalized. Looking forward to what comes next and thrilled this wasn't a PR announcing a reverse split (not that it can be completely excluded from later events).
Looking forward to some news in October. One month to the next 10-Q at the very least, and just slightly longer until the presentation at the Crohn's and Colitis conference. What recent PR did we first hear that the BTD application was under review with the FDA - the 9/20 PR?
presumably before the P2 trial started???
Or are you just trying to make a point that we were not told when they had the initial P2 meeting with the FDA before the trial started? Sarcasm and tone can be hard to detect in message board posts sometimes...
IMO the PR today shows that given IPIX thorough examination of comparative studies and competitors in this space, they REALLY want BTD and also an extremely compelling presentation for potential partners and investment firms. I have to imagine they waited to complete that thorough review before submitting for BTD so they could serve up a clear and easy to understand case to the FDA based on all the facts about their study and others, and why they have the best potential therapy on a multitude of fronts (ease of admin, patient and hospital time and cost savings, efficacy). Seems to me they hope to make it a no-brainer for the FDA to grant them BTD and that may explain the additional time needed to compile the necessary information to do so and request the end of Phase 2 meeting with the FDA.
Next PR could be that they have requested an end of Phase 2 meeting with the FDA???
"Incentives
Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs.[9]"
https://en.wikipedia.org/wiki/Breakthrough_therapy
What are the potential benefits of BTD? Smaller Phase 3 trial required?
Of course, that could change if the Prurisol results are worthy enough to sell the asset outright or partner off in addition to B-OM/B-IBD.
Looks like they are only seeing a little over a 50% price spike on the news today. If we do finalize an agreement, a 50% spike would be pretty abysmal given where we stand currently.
I have to imagine a RS is in the cards for us before the end of the year.
Are we sure they are requesting the meeting to take place in September? Or are they just planning to make the request for the meeting this month?
Edit: Page 7 from 10-K
"In September 2018, the Company plans to submit a request to FDA for an End-of-Phase 2 meeting."
~50 days until the next 10-Q. Last year's was November 8
Ha! Fair enough
Anyone know if the end of phase 2 meeting with the FDA will need to be completed prior to any Partnership agreement?
I ask out of ignorance to our potential suitor's good will during the non-binding term sheet negotiation stage. They only mentioned one Global Pharma in the 10-K so it's unlikely we have other non-binding term sheets as backup options. I don't question IPIX strong trial results in IBD or OM but worry (hopefully unnecessarily) that our potential partner may be holding out to see what else is out there and burn down the clock on our finances. Whoever they are, they have time to wait until November or later while we don't so I am a bit wary of IPIX being toyed with/taken advantage of under the guise of "due diligence". I would hope the potential partner negotiates in good faith but am naive as to whether games are often played in situations like ours.
So the Global Pharma is conducting additional due diligence... Any chance this would relate to the IBD conference in early November? Am I being to pessimistic that they might be waiting to see what else is presented by other companies before they decide they like us enough to sign a binding agreement with IPIX?
Just curious - what is your usual question? I want to make sure I'm not duplicating efforts as I plan to reach out this morning regarding finances.
Thanks for your efforts.
K is not dead. My understanding is once funds are in place and the Oral drug is developed, the company intends to proceed using these new guidelines from the FDA for a continuous, rolling trial through all stages which should be much quicker.
https://endpts.com/fda-drafts-guidance-on-seamless-clinical-trials-for-cancer-drug-developers/
I contacted the company and received a response regarding pursuit of a rolling "expansion cohort" trial through all phases for oral Kevetrin
https://endpts.com/fda-drafts-guidance-on-seamless-clinical-trials-for-cancer-drug-developers/
Looking forward to completion of the development of oral Kevetrin once the company has some cash in hand.
Regarding Oral Kevetrin - would it be prudent to partner for the initial oral-dosing trial? Or would it be likely that IPIX would run an initial trial solo before partnering?
Also, with this newly issued guidance from the FDA, would it be likely that IPIX could perform a rolling "expansion cohort" trial through all phases to shorten development time?
https://endpts.com/fda-drafts-guidance-on-seamless-clinical-trials-for-cancer-drug-developers/
Results should be out next week or the week after if the previous P2a Topline release is any indication. Weren't those released around 37 days post-lock? We are sitting at 34 days post-lock at the moment.
10-Q in the next couple of weeks could shed some light on recent progress..