For months now, everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), its CEO The NaDDir* and his klown krew, have been hyping up the potential for its only product, affectionately referred to as loserlimab, in the Philippines. As with all things Cytodyn, this has been just more ridiculous hype.
Recall when The NaDDir* was making the rounds of every Youtube doctors’ shows? Back on September 22, 2020, on something called the Dr. Been Show, The NaDDir* was not just positive, but VERY VERY positive about the Philippines:
If you can possibly stand it, you can watch the video of that shitshow here.
The hype continued with a press release on October 12, 2020 naming the company in the Philippines that was referred to weeks before:
CytoDyn Appoints Chiral Pharma to Secure Leronlimab for Local FDA Approval in Philippines
VANCOUVER, Washington, Oct. 12, 2020 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today its appointment of Chiral Pharma Corporation, a subsidiary of Philippine New Marketlink Pharmaceutical Corporation (NMPC), to register leronlimab (PRO 140) for potential approval from the local Food and Drug Administration to treat patients with COVID-19 in the Philippines.
In early December the company put up a link to an article about EUAs in the Philippines right on their homepage:
The link leads to an article from CNN, dated December 2, 2020, which curiously enough, actually proves that Cytodyn has no chance for getting an EUA in the Philippines anytime soon.
This means that the data must first be submitted in the home country, which in Cytodyn’s case is the USA, and only AFTER the drug is given an EUA or approval in the home country can it then be submitted to the Philippines for an expedited EUA.
But that didn’t stop Cytodyn from continuing to bamboozle investors about the prospects for an approval in the Philippines. On a December 10th conference call the company made the following claims. Firstly they teased investors with tales of all the revenues that could come in:
Then they spun some nonsense that they will submit for an EUA in the Philippines without the data from the CD12 trial:
And finally that they will submit the application for an EUA the day the order is signed by Philippines President Duterte:
As loserlimab does not have an EUA anywhere, let alone the USA, it is impossible for them to get one in the Philippines. This was further reinforced by the head of the Philippines’ version of the FDA in an interview on December 15th:
“Hindi puwedeng sa Pilipinas unang kukuha ng EUA. Kailangan, meron na siyang EUA sa bansang pinagmulan niya o sa iba pang mga mature na regulatory agency,” he added.
[Translation: We can rely on the evaluation and decisions of mature regulatory agencies and of the WHO. Companies cannot apply for an EUA for the first time in the Philippines. The product must be approved in their home country or by any other mature regulator.]
But that is not the only reason why Cytodyn’s delusions of an EUA in the Philippines are laughable. On December 14th the guidance documents were released, listing the requirements for the EUA.
We already know Cytodyn fails conditions 4, 5, 6, and 7, but what about condition 8, stability? In recent conference calls The NaDDir* has been asked about stability:
It turns out that the current batches of loserlimab (actually 2.4ml vials) only have ~6 month stability testing. Pity that the US FDA requires a minimum of 12 months stability testing:
Failure to meet the stability criteria in the USA would be yet another reason why attempts to gain an approval, in any indication, anywhere, are foolish dreams. This could also be another reason why the company has continually failed to actually refile its BLA for HIV in the USA, or file in the UK, Canada, or anywhere else despite continued promises.
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping