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Biotech / Medical : NNVC - NanoViricides, Inc.
NNVC 1.120-7.4%Jan 9 9:30 AM EST
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From: Colavita3654/2/2019 10:43:47 AM
2 Recommendations

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HardToFind
hpgrant

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The company should hedge its bets and go with the easiest path to drug approval for its topical product, and not necessarily have a one-track mind about just shingles. Genital herpes may actually be a lower regulatory bar to jump over than shingles, given the limitations of a topically applied product for a disease with origins deep within the body. The same animal tox data can be used for both. At the pre-IND meeting with the FDA they should indicate that the same product has potential for treating both conditions, and ask specifically what measures and criteria the FDA would expect for approval in each of the two medical conditions, and only then decide which specific direction to go. In the era of the Shingrix vaccine, a genital herpes cream may actually be more of a money maker for the company as its first product. Also, a single Phase 1 safety trial I healthy volunteers can be designed and used for both shingles and genital herpes, with volunteers applying the cream onto the skin in appropriate body surfaces. This way there is more bang for the buck with the Phase 1 trial - it can be used to support Phase 2 trials for both genital herpes and shingles, and would make it more meaningful and saleable for a big pharma partner. Logical progress and informed medically sound planning with appropriate FDA input on the specific approval criteria should govern the company's actions and decisions at this point, not just a single entity's personal whim or gut feeling.
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