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Sachet packaging is critical to the BTD application and approval. It wasn’t a silly PR, unless one has not examined BTD approval requirements.
It comes under “Innovative steps to insure product readiness for marketing.”
Just to toss a fly in your ointment:
“Most submissions reviewed in 60 days or less*
? Limited types of submissions require 90 days”
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466480.pdf
So, BT decisions are made in 60 days or less, unless it takes up to 90 days. Hmmm.
Not in an area where I can do this now, but before the weekend I will post BTD criteria and why B-OM ticks every box for approval including >10% improvement over standard of care.
A BTD approval, or not, is not a material event until a non-insider gains access to the info which then becomes tradeable info that can affect share price and therefore future share structure. Leo does not have to report a BTD decision until he decides to report, or it gets leaked. Until then, release of the designation can wait until after it has been revealed to any negotiating party holding a CDA, or his own strategic release date.
My point was the 30th of September falls on a Sunday, so someone implied everything has to be done by Friday because no one works on Sundays. That’s nonsense and has nothing, NOTHING!, to do with holding Leo accountable.
So, if all is finished on Sunday 30th Sept., you won’t give Leo the benefit of 3 more days to report it? Sad and suspicious! I mean, what you are saying is it all has to be done by Friday Sept 28, 2 days before the actual drop dead date? Meaningless!
I think the P countdown is a lot like a pregnancy; one begins “expecting” the last 2 months.
Up is down, again. Leo has met deadlines more often than not. What you’re talking about is guidance, where he states words to the effect of we anticipate something in the 3rd quarter. Well, in biopharma trials things happen that are outside the control of the sponsor. It’s foolish, maybe just silly, to hold a CEO to guidance and time estimates when it comes to trials.
So far, everything has come to pass, just not on investor timelines. But, they have come to pass.
Leo doesn’t just work business days. I realize that a shrill cry of “48 business days” adds to a sense of overhanging doom, but in reality there are still 67 days, or more than 2 months. I guess “more than 2 months” doesn’t sound as desperate.
I’ve already explained this too many times. Brilacidin did hit on 3 points. What it didn’t get was a small phase 3 with a SPA, something we were all expecting after Phase 2b answered all issues and questions left from Phase 2a. That ruling from the FDA made Phase 3 too expensive considering the emerging market conditions after 2015.
As a matter of fact, yes they have.
So, are you saying that sidelining approved drugs for future use after go-to drugs meet sufficient bacterial resistance isn’t a problem? Are you saying it’s only an excuse, it’s not a reality?
Because the field currently is very crowded and there is a real fear, very real in fact, that a new drug approval will simply mean it will be held in reserve as a backup to other still effective, but diminishing, drugs.
My advice is to think about it, my advice is not to buy or sell. Just think about it. So, in a sense, it’s advice but not “pro” advice.
Heading into the weekend, keep in mind if you are on the diving board thinking about jumping into the IPIX pool, this is the best risk to reward investment I’ve seen in a while. Time is running out to get in with excellent cost to share leverage. It’s likely to jump another dime by end of next week.
No, don’t mortgage the house or put the purchase on a $10000 limit credit card, but if you’ve got $500 to a grand in your trading or ROTH account that you can afford to never see again, pick up 1k to 2k shares. Some very smart people here posted that they think chances of failure are only 15 to 20 percent, another said about 40 percent. Well, that’s a 4 out of 5 chance of success to a 6 in 10 chance. But dollar-wise, success means at least a 5 to 10 bagger, or 2.5k to 10k on a $500 to $1000 risk.
This is not advice, these are just thoughts for the weekend BBQ.
Because so many posting comments have crapped all over the Phase 2a results and dismissed them as too small a sample and unreliable rather than recognizing those results as dose escalation efficacy evidence and confirmation of preclinical study results.
You should. At least mine is true and will be proven correct. Empty court slam dunk.
For Aspire, it’s not a bet. It’s James with the ball at half court with no one between him and the basket. Just get to the basket, reach up, and stick it in the hole. The primary outcomes are a lock. Anyone who thinks not hasn’t done enough DD. PASI 75 is a lower bar than what was measured in Phase 2a. Anyone who questions that has no idea what they are talking about. IPIX officers discussed this prior to and during Phase 2a.
Regarding the primary outcomes, from what I read in the Aspire agreement for the milestone and the phase 2b primary outcomes, the milestone was met in Phase 2a at 200 mg. There was a clear difference between the treated and the control patients. There is no reason or evidence to think that won’t be achieved again. It’s a very kow bar as a milestone.
Keeping your ear to the track can result in a squished head, especially if one is deaf to train sounds.
According to the SEC and EDGAR filing rules: 1.01 requires the disclosure of material definitive agreements entered into by a company that are not made in the ordinary course of business. so, it doesn’t matter if the event is material, if it is normal, everyday business.
Isn’t manufacturing a drug “ordinary course of business” for a biopharma startup entering or continuing clinical trials? Seems to me a biopharma cannot test product without product. I might be wrong, but I don’t see any events in the list of form 8K or 1.01 amendment that triggers covering a straight forward formulation and manufacturing contract that is a normal course of biopharma business.
Yes, it would be nice if Leo included that the drug manufacturing and packaging can carry through to market, but I’d argue that already exists in the “commercial-grade” language in the Evonik (or whatever it’s called) PR, a PR that reported a “normal course of business.”
Forgive me for not believing you, but I have a day bid in for 5,000 and it isn’t filling. So maybe you are trying to sell on the FANTC exchange (again) instead of the OTC:QB?
Sorry, forgot about FINRA initiated halts. I was thinking only of major event trading halts initiated by company officers ahead of an announcement. Correct me again if I’m wrong.
Um, that’s in the same sentence as “commercial-grade.” Commercial-grade at bulk is different from just cGMP for trial use in phase 3. And clinical development includes more than just clinical trials.
No trading halts on the OTC.
“...why didn’t they say so?” I believe it was indirectly stated in the Evonix PR: “for the bulk production of commercial-grade Brilacidin to prepare for, as well as expedite, its continued clinical development.” Or, maybe I’m reading more into “expedite” and “clinical development” than intended by the PR’s author.
https://globenewswire.com/news-release/2018/04/23/1485361/0/en/Innovation-Pharmaceuticals-Signs-Drug-Supply-Contract-with-Evonik-to-Bulk-Produce-Commercial-Grade-Brilacidin.html
If you are going to discuss biopharma regulations with me, then you need to do some studying on the most basic concepts and FDA requirements, fancy acronyms and all.
You want to simplify something much more complicated than rocket science, the drug approval process. I’m not going to play minutiae with you over things you can just look up. It’s already too damn hard to post from this emerging, 2nd world nation.
There are at least 20 CDAs, so one can assume there are more than one pharma in the bidding for which they are preparing. Having those suppliers in place yields lots of options, including going it alone. Again, it’s what the FDA wants to see whether it’s IPIX solomente, or IPIX and a partner, or a platform buyer.
OTC trades are in 2 parts, each transaction being one part. Market makers execute buys by filling orders, thus leaving an open position or “short”. They then fill that open position with a sell transaction. The fill can be executed at the same price as the original sell, above that price or below that price. Filling an open position with shares sold higher leaves a deficit that needs covering later, which is fine in a rising market. Fills using shares at a lower price leaves a surplus which the MM is free to pocket.
The published short report is nothing more than the number of shares traded as buys that left an open position to be filled later. The vast majority of open positions are filled instantly or within minutes and are a normal part of daily trade executions.
Of course, things are never as straight forward as the basic transaction operations:
http://www.imf.org/external/pubs/ft/fandd/basics/markets.htm
The FDA requires phase 3 drugs be manufactured at the same facility as that to be used after approval. If not, then there is a delay as the fed will require a CMC and cGMP review before final market approval. Having manufacturing and packaging in place for phase 3 avoids that delay.
That was for bulk Brilacidin. This is for formulation into individual treatment sachets.
It’s still rinse and spit. Putting a powder or liquid into sachets doesn’t change the delivery.
If you read the primary outcome, you will know it has already been met. Nothing insider about it. For your convenience:
1. Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12 [ Time Frame: 12 Weeks ]
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 16 Weeks ]
The primary outcome is already met. It’s just a matter of crunching numbers and then reporting.
There is either a BTD in place by 9/30, or there’s not.
There’s either a license or partner with an up front payment of >$10 million by 9/30, or there’s not.
I’m trying to figure out which outcome is open to interpretation by Aspire.
This is what you actually said:
“IPIX should initiate a stock buy back. I keep hearing how its going to be $30/share by years end. makes perfect sense.”
Here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142204426
Yes, we should all read to what we are actually responding.
Good plan. Thanks for showing the kind of support that management (for obvious reasons) won’t. ;-D
“Yes. Brilliant. Thanks for the idea. I’m going to sell all of my shares at bid on Monday and then buy them back at the ask to help promote the stock. big smile”
Ah, take out a loan using deeply discounted shares as collateral funded throughout toxic spiral structure. Do not know anything else that could be used to secure the loan? A great way to lock into a must deal or die with a BP. Amazing business acumen!
So, you think IPIX should use funds earned by selling shares to do a buy back, thus buying shares at a higher price? Makes perfect business sense, if one is intent on going out of business, or intent on issuing more shares to raise more money. Pure genius.