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Rdunn88

02/22/21 8:52 AM

#348010 RE: maxinvest #348009

September 2021? LOL, The virus will be almost gone if that's phase 2...

cabel

02/22/21 8:52 AM

#348011 RE: maxinvest #348009

Maybe turning into a phase 3

cabel

02/22/21 8:54 AM

#348012 RE: maxinvest #348009

Do we have the funds to fund a bigger trial,... hopefully a partner will be announced

LitesOut

02/22/21 9:05 AM

#348019 RE: maxinvest #348009

Still shows March 31 on the clinical trial site.

http://clinicaltrialsregister.ru/search/index1.php?q=IPI-BRIc-201&s=

Rdunn88

02/22/21 9:05 AM

#348020 RE: maxinvest #348009

IPIX, more questions than answers... So now an unknown Russian phase trial is projected to complete in Sept... The key being what phase? And, why was all this info hidden all along? Can't wait for the 10-Q...

x fctr

02/22/21 9:25 AM

#348038 RE: maxinvest #348009

This falls into negative development. But also makes no sense in length of time for this disease and number of participants. Update is identical in all ways except for trial conclusion date. Another delay would be truly exhausting. .

farrell90

02/23/21 10:33 AM

#348419 RE: maxinvest #348009

Do you have a link for that? No mention of change in 10Q.

Good luck,

Farrell

CallMeCrazy

03/01/21 9:11 AM

#349646 RE: maxinvest #348009

More evidence Leo is anticipating B-COVID-P/3 in Russia

Russia Trial date update to sept 2021. New site added.


Additionally, Farrell90 in post# 349576 states:

Most of what concerns you and Mr Locke about the Brilacidin Phase 2 trials ignores the fact that this is an adaptive trial and has the ability to add additional patients and even extend the trial to a Phase 3 seamlessly if Brilacidin is found to be safe and effective. (emphasis added)


Considering this evidence in association with my Sunday post below and I think that in terms of a "go-it-alone" B-COVID P-3 in Russia,I think IPIX is leaving the "realm of possibility" and approaching the "realm of probability".

CallMeCrazy Sunday, 02/28/21 03:21:14 PM
Re: CallMeCrazy post# 349472 0
Post #
349550
of 349643
Could Leo be anticipating B-COVID P-3 in Russia.

In my reference post I assigned a "ballpark" figure of $22M to a B-COVID P-3. I used the average of a study of phase 3's ($19M) and applied a cumulative price increase of 10% and added a million.
https://www.raps.org/news-and-articles/news-articles/2018/9/phase-3-trial-costs-estimated-at-19m-study-finds

Conducting a P-3 in Russia might not even cost that much.
Quote:
The cost of conducting CR in Russia, Argentina, China & India is about half the cost to the US (pages 16 & 17)

https://www.fda.gov/media/91849/download

All of this suggest that the $14M IPIX has on hand might be enough to fund the B-COVID P-3 in Russia. Even if the $14M is not enough and Leo might need to raise a few more millions, the point here is that it appears a IPIX-financed B-C0VID P-3 has entered the realm of possibility.

Here are some 'Advantages of clinical trials in Russia':

1. Data acceptance With adherence to global standards and regulations observed in clinical studies, The FDA and EMA accept data from such clinical trials in Russia.

2. Patient pool
The Russian hierarchical health care system contains a large number of health care facilities across the country which provides substantial access to various patient populations and enables rapid recruitment of study participants. Genetic diversity and high urban proportion.

3. Investigators expertise
Access to educated, experienced, and compliant investigators who are motivated to participate in clinical trials to advance new drug development. There are GCP trained and certified Investigative Sites generating high-quality data.

4. Lower Costs
Russia offers lower costs for conducting clinical trials as compared to the US and Western Europe. Some of the experts have claimed that compared to the US, Russian sites offer approximately 30-60% savings to sponsors depending on the complexity of the study, study-specific procedures, patient population, and etc.

https://credevo.com/articles/2018/07/30/russia-clinical-trial-regulatory-process/

Having a B-COVID P-2 in Russia, judging from the above info, looks like Leo's made another smart move.

IMO, if Leo is, indeed, planning to finance a P-3 in Russia, then he's smart enough to know that he has to line up lots of manufacturing capacity.

I think if there's anyway Leo can pull off a P-3 and bring B-COVID to market, with all those cash-in-hand bulk-buyers waiting, he will.

Longpicker

03/01/21 10:54 AM

#349679 RE: maxinvest #348009

Can you show how you got that info? Thanks