I think this post is worth a share from YMB.
“
LH Top Line Data very soon.
mTNBC Top Line Data also very soon. Data will be sent to fda, our partners (Biomm, MacLeod's and Chiral) and Regulatory Agencies globally.
Soon after, LH Phase 3 trial protocol approval by fda (depending on strength of Top Line Data). Phase 2 trial for mTNBC protocol approval by fda (also depends upon Top Line Data).
Possibility of our partners to gain approval for trials abroad remains to be seen. If data is very good they will be motivated.
HIV BLA resubmission expected mid October to beginning of November. The fda has 2 weeks to respond after they receive BLA. If everything is in order, they will grant a PDUFA date 6 months from the date they received BLA. At that time (or sooner), they will either approve or file CRL or request a phase 4 trial (highly unlikely). PDUFA date most likely in early May (unless approved sooner).
Covid trial (Brazil). Interim data at 145 patients. Dr. Recknor was recruiting 5 patients day. Biomm has 35 sites. It's anyone's guess when patient #145 gets 1st dose. Then 28 days later until final dose. Then follow-up on day 42 and day 60. Some on this board say look for results after day 28. They are either lying or misinformed. Follow-up to day 60 and allow time to gather data and crunch numbers. Time-line depends upon enrollment.
Very possible that EUA will be granted (if interim endpoints met) while we complete trial. This is when we find out how good our partners are. Remember, they are footing the bill. We are only supplying the drug. Personally, I like their (Biomm) confidence.
Obviously, this is not their 1st rodeo. It also speaks volumes to their confidence of Leronlimab. They wouldn't be here in the 1st place unless they were impressed by the data. That's right...their Dr's. and Scientists poured over our data before deciding to invest their time and money. They recognized the potential (just as we investors have). Obviously they don't care what the fda has to say. They obviously have confidence that they can navigate the regulatory hurdles to bring a drug to market in their country. Especially one with zero side effects and multiple indications.
Honest question. Who here has invested only for Covid, HIV, Cancer or NASH? Me neither. I got in for mTNBC but HIV was already in progress. Two bites at the same apple. Soon after I invested, along came 22 Cancer basket trial, NASH etc.
Then came the realization. Will BP stand aside and watch this tiny company take billions of dollars away from them? No way. That's for damn sure. But the fda will make their decisions based on science right? Another eye opener. After connecting the dots, I came to the conclusion that CytoDyn was doomed. But then Dr. NP, Kelly and company took this abroad. Genius move! What would you or I have done?
They secured manufacturing (Dr. NP sold shares to pay Samsung). They secured financing (Dr. NP's strongest suit). They avoided major dilution (unlike former management that's part of Rosenbaum/Patterson Group). They dealt with all the negative forces that were trying to stop them.
They improved their team. They assembled a top notch Advisory Board and tuned out the noise of negative efforts they couldn't control. Eyes on the prize!
They hired a top notch legal and PR firm (to clear any and all obstacles in the path of partnership or buyout).
My biggest problem? Finding the cash to increase my holdings at these prices.”
“
LH Top Line Data very soon.
mTNBC Top Line Data also very soon. Data will be sent to fda, our partners (Biomm, MacLeod's and Chiral) and Regulatory Agencies globally.
Soon after, LH Phase 3 trial protocol approval by fda (depending on strength of Top Line Data). Phase 2 trial for mTNBC protocol approval by fda (also depends upon Top Line Data).
Possibility of our partners to gain approval for trials abroad remains to be seen. If data is very good they will be motivated.
HIV BLA resubmission expected mid October to beginning of November. The fda has 2 weeks to respond after they receive BLA. If everything is in order, they will grant a PDUFA date 6 months from the date they received BLA. At that time (or sooner), they will either approve or file CRL or request a phase 4 trial (highly unlikely). PDUFA date most likely in early May (unless approved sooner).
Covid trial (Brazil). Interim data at 145 patients. Dr. Recknor was recruiting 5 patients day. Biomm has 35 sites. It's anyone's guess when patient #145 gets 1st dose. Then 28 days later until final dose. Then follow-up on day 42 and day 60. Some on this board say look for results after day 28. They are either lying or misinformed. Follow-up to day 60 and allow time to gather data and crunch numbers. Time-line depends upon enrollment.
Very possible that EUA will be granted (if interim endpoints met) while we complete trial. This is when we find out how good our partners are. Remember, they are footing the bill. We are only supplying the drug. Personally, I like their (Biomm) confidence.
Obviously, this is not their 1st rodeo. It also speaks volumes to their confidence of Leronlimab. They wouldn't be here in the 1st place unless they were impressed by the data. That's right...their Dr's. and Scientists poured over our data before deciding to invest their time and money. They recognized the potential (just as we investors have). Obviously they don't care what the fda has to say. They obviously have confidence that they can navigate the regulatory hurdles to bring a drug to market in their country. Especially one with zero side effects and multiple indications.
Honest question. Who here has invested only for Covid, HIV, Cancer or NASH? Me neither. I got in for mTNBC but HIV was already in progress. Two bites at the same apple. Soon after I invested, along came 22 Cancer basket trial, NASH etc.
Then came the realization. Will BP stand aside and watch this tiny company take billions of dollars away from them? No way. That's for damn sure. But the fda will make their decisions based on science right? Another eye opener. After connecting the dots, I came to the conclusion that CytoDyn was doomed. But then Dr. NP, Kelly and company took this abroad. Genius move! What would you or I have done?
They secured manufacturing (Dr. NP sold shares to pay Samsung). They secured financing (Dr. NP's strongest suit). They avoided major dilution (unlike former management that's part of Rosenbaum/Patterson Group). They dealt with all the negative forces that were trying to stop them.
They improved their team. They assembled a top notch Advisory Board and tuned out the noise of negative efforts they couldn't control. Eyes on the prize!
They hired a top notch legal and PR firm (to clear any and all obstacles in the path of partnership or buyout).
My biggest problem? Finding the cash to increase my holdings at these prices.”
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