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Wow, did Aspire tell you this?
Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).
yes it was met in ph2a....
I believe lil k put it best when he said he doesn't care to examine every bit of minutiae that people come up with. i would only add when you do a clinical trial and you hire 2 suppliers then we can talk...
original work, Sounds like minimum requirements in FDA review process....
References:
1.FDA guidance on the “Preparation of Investigational New Drug Products (Human and
Animal)” 1991 (reprinted November 1992).
2. FDA “Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies.”
3. FDA “Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients,” Section 19.
4. FDA “Guidance for Industry: Content and Format of Investigational New Drug
Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized,
Therapeutic, Biotechnology-derived Products.”
5. FDA “Draft Guidance for Industry: Instructions and Template for Chemistry,
Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy
Investigational New Drug Applications (INDs),” August 2003.
6. FDA “Draft Guidance for FDA Review Staff and Sponsors: Content and Review of
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy
Investigational New Drug Applications (INDs),” November 2004.
7 FDA “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing –
Current Good Manufacturing Practices.”
jt, again in your opinion....signing supply contracts for B, forwarding Prurisol to statistical analysis, forwarding Brilacidin to future trials/BTD by showing compliance with suppliers and manufacturers, 3 pltforms in mid-late stage 2 trials with multiple indications, signed cda's, funding through the regulatory process.....shall we go on....yes, soon with P ph 2b results....btw, a reminder???...we have enough string tied to our fingers as reminders now for 1,000 hands...all imo...stay tuned yall
hey JT, in my opinion isn't Leo doing that by 'wrapping up' the approval/BTD process of fda by showing their compliance with the CGMPs such as Evonik and CoreRx?
lilk, please allow me...
that an acquiring pharma can do what it wants to do....to go it alone they say?
seems like an awful lot of trouble to go through to build a turn key supply line, doesn't it?...sheesh..
imo
a bulk producer and bulk supplier - seems like a lot of trouble just to go it alone...why not just keep current methods, unless a massive ph 3 is planned....ipix only has engaged in smaller trials so far....a project such as this may mean partner to undertake such a task imo
threaten a confidential agreement that may already exist for P....hardly. in my opinion, and potential dollars which may also support B for its many indications....not to mention a bargaining chip if they beat otezla....not to mention bargaining chip with breakthrough designation
maybe a bit more inventory to go through yet in regards to consolidation of share price....need few more weeks of 250k day trading to work through...even with buying, selling pressure is only massive in few spots to keep share price in 'check' until larger volume flushes penny traders and the like to price consolidation....look for a bigger push to .52-.54 later in the week, next but who knows when news comes?....until then, the flippers and the like will play the spread until solid push through .68...of course there might be a little give up of a few pennies more to up side but not much higher as we play the spread of 'waiting for news/wheres the news....expect .53-.63 spread until news then bets are off
all imo
all in my opinion, not even 11 days since hard lock announced and 76 days til the end of september....reducing time to make up your mind one way or the the other if you play this spread....
is he still putting data into subsets....in my opinion, who knows where they are in the data analyses, but you are 'putting scenarios in subsets'.....as you describe a nefarious scenario of your imagination of IPIX analyzing data and subsequent share price scenario....
all imo, not if you sold and bought it back to get at lower price...nobody is fooled!
every one who believes that, I have a bridge I can sell you...., probably Aspire selling the bid
sellers tired, now to buy imo
perhaps the 'BD' stands for
* securing client meetings
* Obtaining requests for proposals
* Assisting in proposal development and facilitating presentations at client sites
* Securing contract awards based on above efforts and sales targets
not broker dealer, silly, but business development
in my opinion, wow, really!!! a 7/6/18 chart that predicts the future trading for the following week, not to mention at the same time a negating share price in recent light of current negotiations, established partnerships on distribution, possible future licensing agreements, acquiring funding through regulatory process, etc. especially with news pending on several fronts! Interesting to say the least - imo you may not have something here....seems to me that the duration of days in trying to get ipix to a low/bottom before uptrending again is becoming shorter and shorter....this may be more telling imo....
forgive me on the use of can't if you will you reconsider Aspire selling any time, as in .49.48.48.46.45.44.43?????, if IPIX in my opinion, should IPIX hit any of the 3 milestones and they are sold shares at .50 or greater....will they then be selling below .50....especially in light of .38 warrants to buy more esp if we hit any of the milestones?
if IPIX is funded enough through regulatory filings as they say with the 2 million, will Aspire be selling any time soon and below .50? and, if they do really how much below .50?????
in my opinion,
Aspire can't sell until sp > .50
Before the deal, IPIX was seeing lower lows with any small gains easily eroded with .05 cent flips getting closer to .25 and having a greater chance getting a larger position at a smaller price at the same time raising cash with increasing dilution...
now,the ompany received $2 million on signing the agreement selling 5,263,158 shares at price per share .38
each milestone payment made on achieving milestones = higher share price to buy in potentially
its not that we need to inspect a measly $7 million...but a greater inspection to what this may reverse....
P gets even mediocre results, how much do you really think they need for the 505b ph3.....just what are the chances we get no btd for b.....if btd for b happens, does this wet the appetite of big P......
imho they wont bring it until it best suits them...expect a penny or two push on monday followed by a quote of 'enjoy the pain'....followed by them watching the light volume, if any...and, if so, another push to get the weak hands out....followed by consolidation, followed by a call to say 'when is the P results due'...followed by a small run up...followed by P results where it will be over a million shares traded...BUT STILL FIND THEY CAN'T KILL IT....WHICH BASICALLY KILLS THEM...with a few words of 'don't forget to pray' sprinkled in for effect....AS IF!.....
their logic is simple and SAD IMHO
HOWS THAT FOR A SUMMARY?
apparently someone just opened the lawn chair....
squirrelly notion as respect to safety as you have cited, but also to some of the authors that purport some of these 'said' notions, imo always wanted to know how to spell 'squirrelly'.....i can just hear it now upon b license, 'well, so much for squirrely!'
imho
also see them on the penny ask on the way up :)
imo oh sure there are new investors...
we see it when people start showing up saying when are the P/B results so they can make a quick buck....
so, IF they are trying to mislead investors with Prurisol, where is this listed in regards to the 10k that:
Prurisol trial is halted or it is NOT a part of a drug platform that is being pursued
we are seeing only THE OPPOSITE of your proposal that they are trying to mislead the investor...however i believe that you may be trying to deceive the investor as the Ph2b P trial is still blinded, unless you know something that even Leo doesn't know
aimho
so try tylenol or baby aspirin.
just kidding...just kidding....
:)
a slow drip killing us at .60, please!!! which was swing traders trying to get in on early rally....yes ohhh, the torture to us longs, NOT!.... lololol
this says nothing, imo!!!
The trend will painfully continue -
wow with that language that will show them boy to buck such a trend....
enjoy a nail in a coffin??....death spiral is back???.....like the commercial, these are terrible slogans....how about death takes a holiday....lololololol
you don't say,
you stated i do not know results, yet....
really? sold at .56 - .65 for a porsche on a .10 spread....anyone?
or 9 months at .64-.70, and you sell at .6158....anyone?
wondering who sold at 56-65 & why
anybody catch this from the blog
Given its broad therapeutic profile, Brilacidin is being developed not only to treat serious skin infections, but also oral mucositis and inflammatory bowel disease, with planned extension as topical agent into dermatologic diseases.
note planned extension.....doesn't look like they are holding back on continued trials
Wow, a 40 cent call for fifty days from now, on a thinly traded stock...with many people in this just to make a quick buck....not too mention that results or possible partner may/may not be announced until that time....
pure genius!
imho
dont sugar coat it, just come right out and tell us what you are HOPING FOR! but pls dont use unequivocally in terms of share price as an indicator of trial results....its just equivocal
imho