Hey guys if your new to CTXR and don't know why you invested and been hearing alot about the DMC this and DMC that, DMC halt, DMC June 29th, please read below. These are the highlights from Leonard Mazur's interview on CEOroadshow (June 10th) regarding the DMC (Drug Monitoring Committee) and what the FDA QIDP and fast track status has in store for Mino-Lok!
I am extremely bullish on $CTXR and I can't wait to see what happens in the next few weeks.
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DMC testing looks at the safety parameters to ensure the safety of the product to the general public.
-
DMC looks at your clinical end points to make sure that the product can make it to the end of the trial (Phase 3).
-
Citius had 2 readouts from the DMC. The first readout they said the product was very safe and the second readout they said Citius was hitting all of their clinic end points continue with the trial.
-
Another possible readout from the DMC will be to stop the trial early because it would be unethical to continue because your data really looks well.
-
He goes into if DMC halts the study due to superiority it would change the timeline of the product going into the market and that's where the FDA QIDP comes into play.
-
FDA QIDP (Qualified Infectious Disease Product) is for antibiotics that have made a significant breakthrough such as Mino-Lok and they obtain special priority from the FDA with extra patent protection - looking at about 10 years of runway with zero competition.
-
They are submitting what they call a Rolling NDA (New Drug Application) to the FDA in segments so they can process the data faster to get the full FDA approval.
-
PDUFA date with the FDA means they will give you a response within 12 months. With the QIDP status they will do it in half the time, 6 months.
-
Mini-Lok will get additional regulatory protection through QIDP which gives them an additional 5 years of patent protection plus the 3-5 years they were already going to get hence the 10 year runway.
Drug Monitoring Committee talk starts at 5:43.
https://m.youtube.com/watch?v=EO-6uMbLzPs
TLDR: DMC can halt the study early before the June 29th meeting due to superiority of Mino-Lok. QIDP status will make FDA give them a response within 6 months.
https://www.youtube.com/watch?v=EO-6uMbLzPs
Probably recorded before the DMC data announcement considering Leonard says the DMC read out will happen towards the end of this quarter - but still some good content.
Nothing new though or extremely interesting. Nice surprising Lenny content though :)
Hi all!
Benzinga were kind enough to answer our call to ask Leonard Mazur (chairman of Citius) man to man, what's up with this Pre 14a filing.
Leonard's answer was quite simply, they ran out of shares due to high demand of insider ownership along with their strategy of share based performance bonusses (Omnibus Stock Incentive Plan). I like to reiterate again one paragraph of the actual filing below.
Hope that clears a few things up, and helps to set some minds at ease!
" The proposed increase in the number of authorized shares of the Company’s common stock will not change the number of shares of common stock outstanding, nor will it have any immediate dilutive effect or change the rights of current holders of the Company’s common stock. However, the issuance of additional shares of common stock authorized by the Amendment may occur at times or under circumstances as to have a dilutive effect on earnings per share, book value per share or the percentage voting or ownership interest of the current holders of the Company’s common stock. "
Hey guys if your new to CTXR and don't know why you invested and been hearing alot about the DMC this and DMC that, DMC halt, DMC June 29th, please read below. These are the highlights from Leonard Mazur's interview on CEOroadshow regarding the DMC (Drug Monitoring Committee) and what the FDA QIDP and fast track status has in store for Mino-Lok!
I am extremely bullish on $CTXR and I can't wait to see what happens in the next few weeks.
-
DMC testing looks at the safety parameters to ensure the safety of the product to the general public.
-
DMC looks at your clinical end points to make sure that the product can make it to the end of the trial (Phase 3).
-
Citius had 2 readouts from the DMC. The first readout they said the product was very safe and the second readout they said Citius was hitting all of their clinic end points continue with the trial.
-
Another possible readout from the DMC will be to stop the trial early because it would be unethical to continue because your data really looks well.
-
Leonard goes into if DMC halts the study due to superiority it would change the timeline of the product going into the market and that's where the FDA QIDP comes into play.
-
FDA QIDP (Qualified Infectious Disease Product) is for antibiotics that have made a significant breakthrough such as Mino-Lok and they obtain special priority from the FDA with extra patent protection - looking at about 10 years of runway with zero competition.
-
They are submitting what they call a Rolling NDA (New Drug Application) to the FDA in segments so they can process the data faster to get the full FDA approval.
-
PDUFA date with the FDA means they will give you a response within 12 months. With the QIDP status they will do it in half the time, 6 months.
-
Mini-Lok will get additional regulatory protection through QIDP which gives them an additional 5 years of patent protection plus the 3-5 years they were already going to get hence the 10 year runway.
Drug Monitoring Committee talk starts at 5:43.
https://m.youtube.com/watch?v=EO-6uMbLzPs
TLDR: DMC can halt the study early before the June 29th meeting due to superiority of Mino-Lok. QIDP status will make FDA give them a response within 6 months.
Hey guys if your new to CTXR and don't know why you invested and been hearing alot about the DMC this and DMC that, DMC halt, DMC June 29th, please read below. These are the highlights from Leonard Mazur's interview on CEOroadshow regarding the DMC (Drug Monitoring Committee) and what the FDA QIDP and fast track status has in store for Mino-Lok!
I am extremely bullish on $CTXR and I can't wait to see what happens in the next few weeks.
-
DMC testing looks at the safety parameters to ensure the safety of the product to the general public.
-
DMC looks at your clinical end points to make sure that the product can make it to the end of the trial (Phase 3).
-
Citius had 2 readouts from the DMC. The first readout they said the product was very safe and the second readout they said Citius was hitting all of their clinic end points continue with the trial.
-
Another possible readout from the DMC will be to stop the trial early because it would be unethical to continue because your data really looks well.
-
Leonard goes into if DMC halts the study due to superiority it would change the timeline of the product going into the market and that's where the FDA QIDP comes into play.
-
FDA QIDP (Qualified Infectious Disease Product) is for antibiotics that have made a significant breakthrough such as Mino-Lok and they obtain special priority from the FDA with extra patent protection - looking at about 10 years of runway with zero competition.
-
They are submitting what they call a Rolling NDA (New Drug Application) to the FDA in segments so they can process the data faster to get the full FDA approval.
-
PDUFA date with the FDA means they will give you a response within 12 months. With the QIDP status they will do it in half the time, 6 months.
-
Mini-Lok will get additional regulatory protection through QIDP which gives them an additional 5 years of patent protection plus the 3-5 years they were already going to get hence the 10 year runway.
Drug Monitoring Committee talk starts at 5:43.
https://m.youtube.com/watch?v=EO-6uMbLzPs
TLDR: DMC can halt the study early before the June 29th meeting due to superiority of Mino-Lok. QIDP status will make FDA give them a response within 6 months.
