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Those under Warp Speed (BARDA) had no reason for fast track... Leo applied for fast track because he failed to get approval for CV19 assistance. The hope is that he can, but time is running out as many of the programs have expired or will be...
Fast Track is just that, the process for FDA communication is sped up... Not sure why some believe B is going to be approved or manufacturing is completed? IPIX still has to find proper financing, finish setting up the trial and so on... The current method of diluting shares will not succeed if B wants to be a main player... It's a nice carrot to have (fast track) but look at Absssi... Leo didn't have funding or wasn't sure about P3... We'll never get the real answer even-though they spent millions on 2 Absssi trials...
Nice CV19 site for Active/Expired Grant opportunities... Fast track is a nice option but where's the grants? IPIX needs capital...
https://grants.nih.gov/grants/guide/COVID-Related.cfm#active
Here's a list of BARDA assisted companies... Leo must be last in line or failed the app process? WTH
https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx
Some of the CV19 programs have expiration dates to file applications. BARDA was 10/31/20...
There is no official pre-market trading session for OTC:BB and Pink Sheet stocks. However, there is unofficial trading activity that occurs among market makers between 8:00-9:30 AM Eastern Time each trading day.
Operation Warp Speed Is for vaccines. Therapeutics is under CTAP which Leo mentioned about in previous PRS. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
Doesn't the latest finance deal have 2 million ready to hit the market? The 20 penny range potentially adds another 10 million shares to the outstanding. Sad.. need blowout volume to cash the deal out.... 5 million is nice but not close to ending the diluting machine.
.20 no surprise.... The MFO is dumping at will...
Fast track didn't help Absssi much... It's a nice carrot but everything still has to play out....
Appears today's wall is .22... Tried many times to break through but appears out-of-gas....
Correct, IPIX has had fast tack designation before... The hope is a potential partner or lender might jump onboard with NOW extra incentive built in...
Same trading pattern, up the first 10 minutes then a slow death... Need a kick in the behind after 10AM.....
The key is after the first 30 minutes of trading... The June Kidney press release rallied the entire day and catapulted the June run to .65. Need the momentum guys to return....
His company (Moderna) stands to benefit and would expect him to say that even though he doesn't know for sure. History shows they eventually die off...
I've been saying for a month that fast track FDA approval "after Phase 2" was IPIX's best route.... They do not have funds or time to do a P2/P3...
Past 08:30 no news today... Leo in complete silence about IPIX's future... Those site contracts must not be going so well... The CRO has to do visits whenever they're signed... So much for the trial prep work since September... That was a bunch of BS from some posters here expecting a quick trial start... My late Feb prediction will soon be revised to late March....
Time to sell was the June rally to .65. Lucky to see 20 pennies ever again.
Leo still in silence mode as he figures out how to spin no trial start. Each day is lost revenue potential for the small chance B gets approved.
WTH does Biden's first day have to do with a trial update? The excuses continue to mount...
The reason you start ASAP is the company's current state... If they have to run all 120 at home so be it... Leo doesn't have all year to play pretend biotech... Get the trial going yesterday... Maybe the additional sites needed are for that reason...
Exactly, the RBL delay and now trial start is the difference of IPIX stock being 2 bucks or 2 cents... Heading the 2 cent direction as each day passes on... The 9 month chart has IPIX pegged correctly.
Tell that to Faucci who believes December is when the virus will be contained... Also, younger people (less than 60) who don't have underlying conditions won't have a need for B unless it's severe... The revenue potential diminishes as time moves along...
I'd rather they sink (40 million) into OM/UP trials. At least, the revenue potential is greater since there's no vaccine for OM or UP and there's a larger window for reward then a virus which will be gone in a year.
What revenue potential do you see if they (IPIX) have to run a large phase 3 sometime this summer? Phase 2 costs are around 6 to 8 million... Phase 3, 15 to 20 million? Manufacturing/distribution costs many millions? Add the 4 up and how much revenue potential next winter for B? LOL
Yes, longer than thought and why the CEO should remain silent with forecasts that he can't confirm unless A, B and C occur... No surprise here, been happening for 7 years. Leo is the master of deception and a great stock salesman... However, nobody buys his BS these days... Hence the stock price since IND approval...
The excuses for Leo will continue as the CEO goes silent at the most critical time... Each day/week there's no trial start makes B and the entire process more irrelevant. The cost for phase 2/3 will be higher than revenue potential...
Several times Leo mentioned Q4 in press releases? What was the purpose of providing a time-frame that was never going to happen until the IND was approved? Some here thought everything was ready to go as soon as IND approval? Appears they are not close at all...
Wake us up in March Leo!!! Still signing those site contracts then visits needed followed by recruiting... LOL Q4 never had a chance except provide false hope!!!
Limit day orders drop at market close. Wouldn’t read anything into it. Same as the bids will lower at 16:00. Tomorrow morning will adjust accordingly.
If B saves lives they can make an exception. The FDA can fast track B right into use. Of course, the data better be great for the 120. There’s also the right to try that comes into play if B becomes a household name after phase 2. We’ll see, let’s see phase 2 start which is late.
Quick phase 3? Really? How many subjects and what’s the cost? Leo doesn’t have the time and financing for a P3. If ipix can save lives with 120 what’s 1000 or more prove? It’s FDA quick approval or Bs a failure. Leo doesn’t have financing for the size trial Pfizer and Moderna had.
Phase 3? Your kidding right? There’s no chance Leo will bother with a P3 considering the cost and the earliest it may be completed will be irrelevant. Nobody is going to assist with millions in costs for a late 2021 acceptance. It’s phase 2 with FDA approval or go home.
Not true, 40 percent will not take the vaccines and many who have had the virus won't... So, IPIX's revenue potential keeps shrinking each day. Also, those who have little to no symptoms won't need B...
The Governor of PA had no symptoms even though he tested positive...
Yes, exactly why there's more questions than answers considering the latest PR was not clear. Additional sites contracted and visits still pending with no mention of the overseas application being approved...
Why I asked the question earlier? Can Leo start a trial with 5 subjects or do all projected sites need to be contracted and visited before the FDA can publish the trial? Sure they can recruit along the way if they want to keep adding. They did this with OM... CV19 could have other restrictions with trial start-up...
There has to be an initial total given to the FDA no? If not, why hasn't he started? Leo probably doesn't have a stable total to report? His goal appears to be 120 eventually...
The concern now "why" the added sites needed for 120 patients? Then, they (CRO) have to visit all locations... Did the overseas app fail? Leo's press releases create more questions than answers.
Hope you find employment hang in there...